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DRAFT Report of the NIH/NSF Group on Image Guided Interventions

September 12-13 2002

Sponsored by

• National Cancer Institute
• National Institute of Biomedical Imaging and Bioengineering
• National Science Foundation

Editors

• John W. Haller, Ph.D
  National Institute of Biomedical Imaging and Bioengineering
• Laurence Clarke, Ph.D
  National Cancer Institute
• Bruce Hamilton, Ph.D.
  National Science Foundation

Contributors

• Ferenc Jolesz, M.D.
  Harvard Medical School
• Russell Taylor, Ph.D.
  Johns Hopkins University
• Michael Vannier, M.D.
  University of Iowa
• Vijay Jain, Ph.D.
  University of South Florida

Acknowledgments

Keyvan Farahani, Ph.D., Bruce Hamilton, Ph.D., Edward Staab, M.D., Richard Swaja, Ph.D.

On September 12-13, 2002 the National Institute of Biomedical Imaging and Bioengineering (NIBIB), the National Cancer Institute (NCI), and the National Science Foundation (NSF) held a workshop on Image-Guided Interventions at the Bethesda Marriott in Bethesda, Maryland. The workshop was co-chaired by Dr. Ferenc Jolesz from Harvard University, Dr. Russell Taylor from Johns Hopkins University, and Dr. Michael Vannier from the University of Iowa. Over 60 researchers, engineers, clinicians and federal officials were in attendance to discuss advances in basic imaging science and engineering as they relate to minimally invasive treatments, biopsies, and surgical procedures that improve human health. The recommendations from this workshop will be used by the NIBIB, NCI, and NSF to enhance existing programs associated with image-guided interventions.

Purpose

The purpose of this workshop was to ensure that NIH and NSF programs address important needs and issues associated with image guided interventions (biopsies, surgery, and other image guided therapies). To this end, input was sought from the academic community and other developers and users of image-guided technologies used in medicine. This meeting covered the spectrum of technological advances related to image guided technologies. Thus, input was sought from the community regarding advances in basic imaging science and engineering as they relate to minimally invasive treatments, biopsies, and surgical procedures that improve human health.

Expected/Deliverable Outcomes

Formulation of recommendations by the end of the workshop.
Publications of Workshop Results to be included in the the journal Academic Radiology and National Institute of Biomedical Imaging and Bioengineering (NIBIB) website.

Participants

Fifty-five scientists from engineering, imaging sciences, clinical imaging, surgeons and physicians, commercial firms, NIH, FDA and NSF staff.
Representatives from 22 universities, 7 commercial firms and 3 federal agencies.

Charge to Participants

The NIH and NSF sought specific recommendations from the community regarding advances needed in image guided (IG) procedures, as well as recommendations regarding basic imaging science, engineering and medicine as they relate to IG therapies, minimally invasive treatments, IG biopsies, and IG surgical procedures. Questions identified were intended to drive the development of new technology in areas related to image guided interventions.

Executive Summary

Image-guided interventions (IGI) are commonplace in medical practice and include endoscopy, minimally invasive surgery, stereotactic breast biopsy, as well as many ultrasonographic and fluoroscopic procedures. A planning workshop sponsored by NIH and NSF was held to identify the needs, opportunities and issues associated with future advances in image guided interventions (biopsies, surgery, and other image guided therapies). A group of academic, industrial and government experts in medical imaging, surgery, and regulatory affairs met on September 11-12, 2002 to advise NIH and NSF on these matters. This meeting covered a broad spectrum of technological advances and applications related to image guided interventions.

The requirements for IGI have been evaluated in the past. , At this workshop, recent progress in the field was reported to identify new opportunities. Clinicians who are experts in their respective fields were consulted to identify unmet needs in this planning meeting.

For the purpose of this workshop and report, IGI is defined as a patient encounter where images are obtained (within or immediately before a procedure) and used for guidance, navigation and orientation in a minimally invasive procedure to reach a specified target under operator control. Common requirements for all IGI are a source of images, real time interactive display linked to the intervention with a means of target definition in the context of real 3-D space (as distinguished from the abstract image space).

The global market for minimally invasive image-guided interventions is currently over $3 billion, though less than 15% of all surgeries are performed using a MI-IGI approach.

IGI has several advantages and a few disadvantages. The most positive features of IGI are its less invasive nature and efficiency – both in time and cost. The higher precision of IGI may result in fewer complications and less normal tissue damage, with assurance that the procedure has been completed as intended, thus reducing the need for rework. And the public prefers a high technology approach whenever possible, leading to rapid clinical acceptance. The disadvantages are that IGI may add unnecessary complexity and cost when the procedure can be accomplished without images – such as in the case of palpable lesions. Images may be overinterpreted, leading to unnecessary procedures due to overdiagnosis. Some IGI systems do not have the ability to update the images in the midst of a procedure, so the images being used may be incorrect. IGI procedures may place special demands on the operator for experience and training, and special equipment is required that may not be widely available.

In some clinical applications, IGI is the standard of care. This is true, for example, in laparoscopic cholecystectomy, stereotactic breast biopsy, stereotactic radiosurgery, functional endoscopic sinus surgery, and 3D conformal radiotherapy to name a few. Clinical trials of IGI have been reported, and among these the RTOG found that image-guided 3D conformal radiotherapy of the prostate with dose escalation increased the cure rate without excess complications in a multicenter trial.

A new imperative for IGI arises as a result of screening tests for cancer and other diseases (especially coronary artery disease) where a diagnosis is needed and treatment administered in an asymptomatic at risk population found to have early disease. In such cases, IGI is virtually the only alternative for management of individuals who have a positive screening result but no overt signs of disease. Given that false positive screening test results are common (e.g., 75% of positive screening mammograms are falsely positive), and patients with positive screening tests suffer high anxiety and stress from knowledge they may have cancer or heart disease, a rapid, reliable and cost-effective means of diagnosing these individuals is needed. IGI is most promising, since (in cancer, for example) a diagnosis can only be made and treatment started when histopathological results are available that must come from tissue sampling. The biopsy procedure may be combined with the administration of therapy. Stereotactic breast biopsy is a common example. Screening mammograms are done, followed in positive cases by a biopsy. In the past these biopsies were done in the operating room with a lumpectomy. Today, it is common to diagnose breast cancer with a core needle biopsy rather than open procedure, lowering the cost and associated invasiveness. Similar procedures for the lung are needed, as CT screening progresses and candidate small lung cancers are identified. At present, many of these lung CT screening patients will undergo a mini-thoracotomy and partial lung resection. An image guided minimally-invasive procedure would be preferable, however. The scenario for lung cancer screening is complicated by the detection of “incidentalomas” in the liver and especially adrenals. These benign lesions cannot be diagnosed by imaging alone, so IGI is necessary.

IGI can provide a new option for care of patients, such as the screening detected lesions described above, that may not exist today. Given the benefits of IGI in breast cancer diagnosis and prostate radiotherapy, many patients and their clinicians would opt for this approach if it were available. Thus, there is strong motivation to adapt and extent current IGI technology for use in new applications, especially common diseases where the options for interventions do not currently include IGI.

It is clear that image guidance improves therapy as demonstrated by the improved survival in prostate cancer treated with IGI 3D conformal radiotherapy (RTOG trial), and by the widespread acceptance and use of IGI stereotactic breast biopsy in patient with positive screening mammograms.

The specific medical applications that can benefit from the application of IGI technologies are 1) patients with positive screening tests – who are asymptomatic individuals at high risk for having early stage disease, such as cancer or coronary artery disease, 2) neurosurgery, 3) orthopedics, 4) vascular surgery, and 5) general surgery. Virtually any open procedure could be converted into an IGI with appropriate technology.

The challenges and issues associated with image-guided diagnosis and therapy include exploitation of IGI in areas where there is no currently widely accepted minimally invasive alternative. The goal should be to establish IGI as the standard of care, which will require convincing proof of benefit – both in cost and outcome – that can only be established by clinical trials. The design of IGI systems should bear this requirement – that the system itself facilitates trial procedures for data gathering, quality control, consistency, reduction of intra- and inter-operator variability, and widespread availability at a cost competitive and preferably lower than current practice.

Among the specific technologies and methods that show promise for advancing IGI and need to be developed and applied to diagnostic and therapeutic procedures are demonstration projects using the “operating room of the future” where imaging modalities are integrated with all other OR technologies in a seamless fashion. Many of the opportunities have not been fully developed and evaluated, including advanced CT (or CT/PET) and MRI systems in OR environments, multimodality imaging in real time, synergies among various technologies, and better standardization of interfaces and control structures. The issues of user interface design and evaluation, reuse of surgical experience captured by the informatics infrastructure, training of new operators and augmentation of human performance (by robots, for example) are among the most important priorities in future IGI development.

The NIH and/or NSF should actively address the challenges and facilitate the realization of the benefits associated with IGI by sponsoring research in this area. Realizing that an integrated approach is necessary where multiple technologies (real time multimodality imaging and display, surgical robotics, high performance computation and networking) are necessary for success, the establishment of a national persistent infrastructure led by centers of excellence is strongly recommended. These centers (and more than one is needed) should engage collaborators at multiple institutions to pursue a broad portfolio of technology development and applications projects. Work in IGI is intrinsically multidisciplinary, and support provided by NIH and NSF should emphasize the development of teams to pursue these objectives in a decentralized fashion with special attention to the interfaces between their components and existing technologies or components developed by others. As such, coordination of effort with standardization of communications protocols, expertise in man-machine interfaces, and special attention to the needs of clinical trials that will test and evaluate the technology in real world applications are unique aspects of IGI.

Workshop Objectives

Image Guided (IG) technologies are rapidly advancing along parallel paths namely, IG biopsy, IG Therapy and IG surgery as required for screening, diagnosis and treatment of different diseases. IG technologies are very complex and multi faceted as they include:

(a) Cutting edge imaging methods for image guidance, including anatomical, functional and recently molecular imaging methods. Imaging methods may include external tomographic approaches and/or localized imaging probes or other image guided sensors. Also included are computer software and other components that are all part of the ‘integrated IG system'.

(b) Physical IG biopsy methods where there is a critical need to improve sampling techniques for verification of the disease status of an organ system or lesion (for example, to permit correlation of molecular signatures using tissue array analysis with in vivo molecular or other imaging/spectroscopy signatures).

(c) IG imaging/spectroscopy, in vivo biopsy methods as an alternative to conventional physical biopsies (laboratory pathological/histological methods) In vivo methods might include such things as optical fiber, catheter-based systems and/or miniaturized US or MRI for localized measurements. Both endogenous contrast and or use of molecular probes could be included in these measurements.

(d) Therapy methods that use various energy forms for localized treatment such as physical based methods that require IG (optical, RF, focused-US or cryo-therapy) or the use of systemic or locally administered drug interventions such as gene therapy.

(e) An emerging array of surgical tools for a priori and real time intraoperative image guidance, visualization, or other intervention systems including robotic methods to improve precision of surgical tools and real-time feedback methods to verify the success of the treatment or surgery

Generic Scientific Issues:

(a) There are numerous components of existing image guided technologies that are generic with relation to clinical applications. Some examples of the generic aspects of image guided therapies and interventions include:

(b) Image acquisition - Improvements in image acquisition (3D techniques, quality, resolution, accuracy, etc.) and imaging devices will inevitably lead to improved image guidance.

(c) Image processing - Segmentation of critical structures, enhanced image processing, the application of electronic atlases, deformable models, etc. can be used to deliver important information at the point of patient care.

(d) Optical or Electromagnetic Guidance Systems - Infra-red tracking of the 3D position of surgical instruments or electromagnetic tracking of catheters or other devices inside the body are examples. Tracking of instruments is done to relate real-world anatomy to the virtual anatomy of the image.

(e) Clinical examples of image-guided therapies that do not include cancer biopsy/treatment include embolization of arteriovenous malformations (AVM), vertebroplasty (injection of bone cement into vertebra), laparoscopically-assisted surgery, stent placement, pedicle screw placement and many others.

(f) There are many common elements among methods of image guided interventions. There is a potential for promoting a more comprehensive engineering system approaches for their design, including shared modular design approaches, dissemination and implementation on similar platforms.

(g) The development of molecular imaging will greatly impact target identification and assessment of the intervention. The premise of a well-defined target for treatment will be challenged. Thus molecular as well as functional spectroscopy imaging (CSI) will set higher performance standards for IG both in terms of hardware and software and the need for real time execution.

(h) There is a critical need to include the next-generation of image processing and IG software methods, as well as pattern recognition methods for image data interpretation. Next-generation methods will include real time implementation.

(i) Barriers that impede the progress for IG technologies and their dissemination include the need to develop a broad consensus for: (1) characterization of system response and system validation methods and related standards, (for example in terms of the accuracy and precision of IG software and hardware components), (2) methods and standards for assessment of tissue deformation and related hepatics, (3) visualization methods and standards including 3D displays and virtual reality, and (4) methods and standards for verification of therapy or interventional methods (i.e.; verification using feed back methods such as a measurement of the biological effectiveness of the intervention).

(j) The performance metrics of IG methods are very different from the methods for the evaluation of diagnostic imaging systems in that there are significant constraints on overall system performance. Furthermore, there are specific requirements for real-time implementation in the therapist’s, interventional radiologist's or surgeon’s environment.

(k) The clinical outcome metrics for IG interventions are very difficult to measure and the variability of IG methodology and assessment methods adds to this difficulty.

Cancer Specific Scientific Issues:

(a) The clinical Impact of Molecular Imaging: There is an opportunity to take advantage of recent advances in functional and molecular imaging methods that may provide a means for IG systems to improve: (1) the sensitivity for identification of the spatial distribution and number of target lesion(s), (2) the detection of microscopic cancer involvement in the vicinity of the tumor bed, (3) the specificity for cancer diagnosis and characterization (benign verses malignant), (4) the prediction of response to any form of IG intervention, and (5) methods that support deterministic means for patient selection for IG therapy.

(b) Logistical IG Issues: There are many IGI issues that may be cancer-specific including: (1) what to biopsy within the field of the imaging sensor, (2) ability to scale through different FOV's to target different lesions in near real time, (3) where to biopsy within a given lesion, since it is often not homogenous, as required for tissue array analysis, (4) feasibility for diagnosis and treatment within a given clinical protocol, that would require real-time diagnosis, (5) specific treatment selection for a given lesion, (e) ensuring all lesions are similarly treated and (6) inter- and intra-operator variability in performing IG procedures for treatment of multiple lesions as opposed to a single target site.

(c) Suggested Targeted Applications: Improved methods for (a) IG biopsy for lung cancer classification (to include small nodule or focal opacity characterization, of less than 5 mm in size) that may require robotic methods or other advances to improve localization and sampling accuracy (modalities: CT/PET), (b) IG inter-operative biopsy methods for the determination of microscopic cancer such as from prostate, for example, using MRI/MRS, TRUS or molecular imaging methods (PET/optical probes), (c) IGB, IGT and IGS for the liver, breast, and kidney cancer, each of which pose different procedural problems.

(d) Feedback Mechanisms: There is a need to develop methods for measuring the biological effectiveness of any form of IG intervention. Are there associated metrics for possible intermediate "IG" surrogate outcomes? For example, there may be an opportunity for real time tissue array analysis and correlation with in vivo finding for small animal cancer models

General Questions

1. Does image guidance improve therapy? If so, how is this demonstrated?

2. What are specific medical applications that can benefit from the application of IGI technologies?

3. What are the challenges and issues associated with image-guided diagnosis and therapy?

4. What specific technologies and methods show promise for advancing IGI and need to be developed and applied to diagnostic and therapeutic procedures?

5. What can the NIH and/or NSF do to address the challenges and facilitate the realization of the benefits associated with IGI

Specific Questions

6. What are the barriers to developing IGI techniques?

7. How do we get IGI techniques through the regulatory agencies/

8. How do we create public/private/government initiatives to move this field forward?

9. Are there any IP issues that are unique to this field/?

10. What methodologies should be used to evaluate these techniques?

11. How do we get patients to agree to these trials? What are the consent and IRB issues?

12. What are the clinical challenges for translation research associated with image guided diagnosis, biopsy, surgery and therapy? What are the performance requirements for IGI?

13. What are the clinical requirements for improved target recognition using functional and molecular imaging?

14. What will be the impact of improved resolution and other aspects of imaging system performance (especially contrast)?

15. How will monitoring and evaluation IGI (e.g. response and outcome measures) of IGI be accomplished?

16. What are the differences in requirements for mega systems and smaller scale systems? What are the IGI requirements for integrated systems?

17. What is the multidisciplinary nature of IGI and its social/cultural effect on medical and technology areas?

18. What are the resource requirements for IGI research?

19. What are the standards for performance, translation and dissemination of critical technologies?

20. How will clinically useful IG technology be developed?

21. What are the target issues of system engineering?

22. Discuss the systems approach for software development, validation, standardization, distribution, and open source software distribution.

23. What is the potential for grid based distributed research resources?

24. How will software technology be transferred?

25. What is the potential for real time implementation platforms?

26. Does Image Guidance Improve Therapy? If so, how?

Summary of Recommendations

Requirements

• Clinical needs
  • Pre-trial (IDE from FDA)
  • Trials (for FDA approval)
  • Target definition
  • Speed ("Real time")
  • Ease-of-use
  • Image update capability
  • Visualization
  • Variety of end effectors
  • Multimodality
• Barriers
  • Communication
  • Champion
  • Operator training
  • Limited domain of application
  • Cost and regulatory barriers
  • Complexity
  • Lack of standards
  • Geography

Integration

• Components - Enabling technology
  • Communication between and among system elements and user(s)
  • Human factors is critical
  • Design for evaluation (QA, RCT, DFSS)
  • Integration: technical; workflow
  • Plug and play capability (h/w & s/w)
  • Move components between systems (to/from centers of development)
  • Teleoperation (?)

Standards

• Standard of care: resistant to change
  • De facto requirement that any new system must meet/exceed current practice
• Special purpose systems have been successful
  • Simple robot (laparoscopy assistant)
  • Image-guided radiotherapy
  • Stereotactic breast biopsy
• Unable to reuse experience
• Single-center approach to high end requirements
  

Who Needs IGI?

• Customer (patients & family; referring clinicians; payors) demands options
  • Implies that they are selected (tailored) to individual requirements
• Surgeons / interventionalists - which could ultimately be almost any practioner
  • For example, all dentists perform "interventions" - Will we redefine the role of physicians (blur the line between diagnosis and therapy)?

Axioms

• IGI is intrinsically multidisciplinary
• Real time means fast enough that system latency is not a hindrance
• "Good enough"; "least burdensome"; "substantially equivalent" are sufficient to serve real world needs
• Systems are semiautonomous; human operator is ALWAYS included

Common Themes

• Communications between/among people, components, systems, institutions
• Real time – necessary, but seldom achieved
• Combine more and more elements in a unified approach
• Screen + diagnosis + therapy
• More, more, more – modalities, displays, robots, etc.
• Manage expectations – since there is strong public interest
• Proof of benefit is necessary
• Continuous improvements
• Reuse experience, monitor performance, update systems
• Current practice in engineering of IGI systems is antithesis of "extreme programming" where daily, weekly, monthly - interaction among all participants is the rule

Imperatives

• Must break out of single institution mold
• Interfaces, standards, communications are key issues
• Must be "real time"
• More is better, but with lower cost, less complexity, increased ease-of-use, automated
• Open source software and middleware foster collaboration – suggest that centers should take the lead in persistent virtual infrastructure for IGI
• Should focus on major effect – prevalent diseases in early stage, standards, collaborative science, reduction of operator variability

What we Don't Need - Application Domains

• Many: brain, lung, prostate, most body regions + organ systems; variety of pathologies
• Requirements vary according to domain:
  • Willingness of neurosurgeons to champion IGI is impressive and sets the standard
  • In lung, tissue sampling of small screen-detected nodules by "ordinary" radiologists with few complications is major problem
  • In prostate, FN random biopsies are common and target definition is problem
  • Some of the most important potential application domains (e.g., general surgery, oncology surgery, orthopedics) are less well developed

Promising Technologies

• Optical, CT, MR, US
• Especially combined modalities
• IGI treatment planning & simulation
• Synergistic contrast agents and instruments (sensors/effectors)
• Open source and collaborative science infrastructure

Evaluation

• Synonymous with quality assessment; validation
• Implies measurements, common protocols and comparison with established "state of the art"
• Performance, usability, flexibility, extensibility
• Testing should include intended application (e.g., organ system, body region, specific pathologies)
• Standardized tools for evaluation / QA

User Interface

• Familiar and consistent with current practice (e.g., image types)
• Tailored to application
• Present "new" real time images in context
• Haptic OK, but may not be essential
• Can overload the operator - KISS

Next Steps 

• Translate requirements into specifications
• Verify that specs are achieved
• Clinical applications must guide development
• Inter-institutional collaboration using persistent infrastructure (e.g., grid)
• Limited series of evaluation units into test phase (e.g., evaluation consortium)
• Common experimental platform replicated at several sites
• The operator/user is key
• Incrementalism is rewarded by regulatory authority; include FDA in the development cycle

Common Tasks

• Extraction of geometry from images
• Visualization of instruments in context; multimodality registration
• Target definition
• First guess treatment plan
• Plan optimization
• Plan verification and validation

Suggestions

• IGI is successful in clinical radiotherapy and stereotactic breast biopsy
• May be useful as case studies of how IGI evolved to solve real world problems
• Study and evaluate their experience and disseminate the results outside their narrow domains (to entire IGI community)
• Can we apply their experience in other domains?

IGI Procedure Paradigm Motivations

• Quality assurance for IGI
• Interoperability: plan IGI in one institution and perform the procedure in another
• Capture plans and procedures
• Enable reuse of prior experience
• Evaluate (compare) procedures: IGI vs. non-IGI, for example Multicenter Clinical Trial QA Process

3D Conformal Radiotherapy Data Exchange Standard

• Conclusion #1
  • Major progress in IGI since previous plans (e.g., Industry Canada and Scibermed, etc.) were formulated
  • This workshop is timely and fulfills an important need
  • Many new and promising IGI component technologies
  • Opportunities exist at basic, translational and applied levels in multiple disciplines
  • FDA has considered IGI and approval mechanisms are defined
  • Several very large and capable groups in major centers dedicated to IGI have been productive in projects with broad potential applicability
  • Clinical success with stereo breast bx and IGRT serve as a model of how technology development can change the standard of care in medicine
• Conclusion #2
  • This field is evolving rapidly and periodic planning / updates are important
  • Training of developers, users, staff is essential
  • More collaboration opportunities that bring together surgeons, radiologists, imaging scientists, computer scientists, physicists, etc. are necessary – and strategies were formulated (e.g, web)

Breakout Session Reports

SESSION 1 (RED GROUP): FUTURE CLINICAL REQUIREMENTS AND TRANSLATIONAL RESEARCH BARRIERS

Barriers

• Safety of new interventional devices: who's responsible
• Liability of new IGI procedures
• Lack of demand (ROI)
  Physician acceptance
• Cost of acquisition of rapidly evolving technologies
• Reimbursement & payment for IGI procedures (oper. cost)
• Differing workflow and project planning among disciplines
• Proof of concept (does this work, ? adverse patient selection)
  Study design issues (e.g., how specific to site, path, modality)
• Methodologies: Randomized trials vs. alternatives
• Measures of success and failure
• Generalization of trials among various degrees of expertise
• No support for limited dissemination of technologies
  for validation

Recommendations

• Rapid & automated image fusion & display
•  With real-time elastic, deformable registration
• Including integration of optical/endoscopic & radiologic images
• Goal is platform-independent methods
• Broad clinical roadmap for academic/industry development:
• First, inter-modality single vendor segmentation & registration
• Next, inter-vendor single modality segmentation & registration
• Then, common display and other characteristics
• Development & integration of imaging & therapy
  Requirements/standards - an IGI "DICOM" that works
• Inter-disciplinary forums to make recommendations on clinical requirements for IGI - to include pertinent physician, scientist, vendor communities
• Collaboration among imaging & interventional device manufacturers
• Development of multi-purpose IGI tools (commonalities)
  • Cross specialty
  • Cross organ systems
  • Cross pathologies
• Funding that encourages such collaborations
• Maintain organ system & pathologic specific validation
• Standardized toolkits for module validation (phantoms)
• Support for limited dissemination of "home grown" systems
• High-tech to low-tech IGI transfer
  Development of pseudo real-time alternatives to open interventions
• Validate the anatomic sites and conditions appropriate for such IGI
• Use these early successes to build demand for the next steps
• Congruity of treatment & target border/volumes
• Reliable and repeatable positional information
• Development of adjunctive tools for targeting, monitoring, assessing IGI results
• Contrast
• Combination imaging and therapeutic agents
• Virtual reality training systems

SESSION 2 (GREEN GROUP): TRANSLATION OF CLINICAL REQUIREMENTS TO TECHNICAL REQUIREMENTS AT THE COMPONENT AND SYSTEM LEVEL

Recommendations Regarding Components

• Develop organ / disease specific imaging contrast agents and optimize related imaging system components to enhance specificity (MR and ultrasound in particular).
• Develop minimally invasive probes which can distinguish malignant from non-malignant tissue (e.g., optical coherence tomography). May require facilitation of technology transfer from other industries.
• Focus on low-cost / low-tech solutions for the "masses"
• Develop imaging techniques for improved resolution (i.e., at the cellular / nucleus level).
• Develop 3D visualization hardware components and software techniques to optimize the communication of relevant information to the clinician.
• Develop techniques for automatically registering and tracking deformable tissues.
• Develop new technologies for tracking anatomical targets and instruments / delivery devices.
• Explore tera-hertz imaging and other new imaging modalities.

Recommendations Regarding Systems/Applications

• Encourage initiatives that include strong systems engineering components.
• Develop clinical accuracy requirements on a per procedure basis and create associated "gold standards".
• Prioritize the need for minimally invasive techniques. This will help identify the specific technology problems that must be addressed.
• Develop new methodologies and criteria for the cost-benefit analysis of IGI systems.

Recommendations Regarding Process

• Assist both investigators and industry to resolve conflicting Federal Agency requirements (e.g., FDA data requirements vs. HIPAA).
• Establish grant mechanisms that require collaboration between engineering and biology.
• Support education of clinical/technical liasons (e.g, MD- Ph.Ds).

SESSION 3 (BLUE GROUP): PLATFORMS FOR OPERATIONAL STANDARDS FOR IGI

Recommended funding areas for important and unsolved problems and issues in IGI:

• Systems Modeling
• Operational Interfaces
• Role of the Grid in IGI Collaboration
• Data Transmission/Latency
• Representation of Uncertainty
• Scale Space Stitching
• Validation:
  • Figures of Merit
  • Test Phantoms/Data Sets
  • Formal & Secure Methods for Systems Validation
• Quality Assurance
• Data Exchange Standards
• Operational Procedures
• Role of Open Source
• Dissemination & Replication of Experimental Platforms
• Middleware
• Working Group (meet regularly)

SESSION 4 (YELLOW GROUP): RESEARCH CENTERS AND RESOURCES FOR IGI

Research Centers

• IGI Centers (NIH, NSF)
  • Big (~10M) to Small (~1M)
  • joint review and joint funding should be explored
  • with a single to few focuses
• Multi Clinical/ Multi Technology partnership
• Education
• Clinical Test
• commercialization - consortium - this can be a center of its own
• asking all of goals - too much (?)
• Evaluation criteria and methods
• cooperative agreement with simplified oversight

Resources to Promote Clinical/Technology Interaction

• Extend Training grants
• Extend/create MD/PhD Program Fellowship
• Research funds explicitly supporting clinical-technology collaboration
  • clinical resident/fellow (100%) + attending (x%)
  • postdoc/grad student (100%) + eng. faculty (x%)
  • funds for eng./materials/lab
  • support for visiting faculty
  • collaboration initiation grants

Resources for Dissemination and Shared Development

• Centralized Clearing House
  • database
  • hardware - Tools, Devices
  • Software
  • Market studies
• Open Software development of designated areas
• Limited dissemination of experimental prototypes
  • Middleware
  • Software
  • Tools, devices
  • Includes funding for modest reengineering/replication/support
• Virtual environments -- as appropriate
• GRID type shared computing, data, etc resource for IGI
  • develop and make available to IGI grantees
• Shared facilities for small scale validation and test
• Working groups & consortia

Funding Recommendations

• Support more personnel
  • clinician’s time
  • Fellowships to exchange people among different organizations
  • Engineering support (NSF does not support “engineers”)
• Research grant structure
  • Single (NIH requirement) vs Co-Pis
  • Required co (C+T)-Pis
  • Review process - getting appropriate reviewers, study section
• Industrial partners as participants in grants
  • IGI is a small division of a large company
  • industrial funds and matching funds
  • explicitly fund engineering for support of integration (e.g., open interfaces)
• Support for working groups and consortia

SESSION 5 (PURPLE GROUP): CLINICAL MODELS - LUNG AND PROSTATE CANCER: BIOPSY AND PERCUTANEOUS METHODS

Clinical Model: Lung IGDT

• Diagnosis/management of small nodules
• Target area of abnormality
  • Multi-modal fusion
  • Molecular markers & functional imaging
• Trajectory planning
  • percutaneous & endo-bronchial approach
  • 3D & multi-planar visualization
  • Real-time tip-specific tracking /imaging
• Development of steerable devices
  • catheters & endoscopes & needles
• Collaboration among imaging and device industry
• Development of Cath-based tissue specific devices (i.e., OCT)
• Development of image-guided robotics
• Risk reduction and management (PTX control)
• Real-time therapy monitoring (temp., tissue viability)
• Simultaneous vascular mapping

Clinical Model: Prostate IGDT

• Improvement of target definition:
  • MR: MRSI, CED MRI
  • Ultrasound techniques: contrast agents / 3D & Doppler
  • Optical spectroscopy
  • Molecular / physiologic tumor markers
• Guidance / Planning
  • Multi-modality image fusion
  • Interactive image navigation software
• Physiologic & predictive models for bx/tx decision-making
• Real-time feedback mechanism
• Delivery systems: computer-assisted device manipulation
• Real-time treatment monitoring: Reduction of side-effect profile

SESSION 6 (ORANGE GROUP): IMAGE GUIDED THERAPY AND RADIOSURGERY

• Molecular Imaging
  • tissue and organ specific probes / contrast
  • microfabricated instrumentation for in vivo analysis
  • and tx
• Mechanisms for collecting clinical data are needed.
  • potential support for a distributed database with appropriate security
• Mechanism for quick Phase 1 clinical trials of IG procedures (NIBIB?)
• Mechanisms for Equip funding, Tech development (tune existing, develop new mechanisms)
• Contrast DOD vs NIH experience
• Intellectual property / conflict of interest difficulties – can agencies help to resolve these? Some universities are very good at this, some very inept. In Europe, government facilitates IP development
• Difficulty in getting relevant information (images, coordinates, etc) out of commercial systems
• Technology needed
  • Disposable MRI guidance
  • deformable registration – full organ system modeling
  • Pre op with intra op image registration
  • Image to physical space registration has not been recognized on the national level. Different from image-image registration.
  • biodegradable fiducials
  • improved use of US
• Study section behaviors
  • reluctance to fund technology development
  • reluctance to fund equipment
  • confidentiality / conflicts