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Imaging in Parkinson's Disease

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2003 Event Series Calendar

The Role of Neuroimaging in Parkinson's Disease
July 9-10, 2003

Westin Embassy Row Hotel
2100 Massachusetts Avenue, N.W.
Washington, DC 20008

AGENDA

Day 1: Wednesday, July 9, 2003

8:30 AM Continental Breakfast
9:00 AM Introductions
Bernard Ravina, David Eidelberg and Robert Holloway
9:15 AM I. Biomarkers and Surrogate Markers:
Moderators: Robert Holloway and David Eidelberg

A. Biomarkers and Surrogate Markers R. Holloway
B. Statistical Fundamentals N. Lange
C. Regulatory Perspective R. Katz
D. Lessons Learned from MRI in MS H. McFarland

II. Discussion:
1) What are the conceptual and statistical differences between a biomarker and a surrogate marker?
2) How does this distinction influence their clinical applications?
10:45 AM Break
11:00 AM III. What Does Imaging Measure?
Moderators:David Eidelberg and J.W. Langston

A. Assessment of Neuroimaging Techniques C.W. Shults
B. FDOPA D. Brooks
C. Dopamine Transporter K. Marek
D. Vesicular Monoamine Transporter R. Albin
12:30 PM Working Lunch

E. Issues in Measurement E. Ahlskog
F. Data Modeling V. Dhawan
G. Image Processing and Interpretation N. Lange
H. Technologies/Ligands in Development R. Innis

IV. Discussion:

1) Where do these ligands fall on the pathway of basic mechanisms of disease to clinical manifestations and exactly what processes do they measure?
2) How can sources of confounding (other biological processes or alternate routes to clinical outcomes), like pharmacological regulation, be assessed in animal or human studies?
3) What barriers are there to these studies in #2 (short-term test, retest studies) and what might new technologies contribute to #1 and #2?
4) Is the relative inaccessibility of imaging data modeling and analysis an impediment to wider acceptability by the research community and FDA and can this process be more "transparent"?
3:00 PM Break
3:15 PM V. Imaging as an Adjunctive Measure or Surrogate in Clinical Research: How Does Imaging Relate to Clinical Measures?
Moderators: David Eidelberg and Karl Kieburtz

A. Current Uses of Imaging J. Stoessl
B. FDOPA D. Brooks
C. Beta-CIT K. Marek
D. Clinical Measurement Issues R. Holloway

VI. Discussion

1) What is the relationship between these ligands and clinical measures and how much agreement should there be?
2) How might the properties of the test differ depending on clinical use?
3) What additional information is added by the use of imaging as a biomarker?
4) What further clinical studies are needed to determine if imaging can be used as a surrogate measure and what study designs would be convincing?
5) How can the issues of disagreement on the diagnosis of PD based on clinical and radiological criteria be dealt with what are the implications for randomization, ITT analysis, and the generalizability of results?
5:30 PM Adjourn
(Dinner on your own)

Day 2: Thursday, July 10, 2003

8:00 AM Continental Breakfast
8:30 AM I. Applicability and Logistics of Multicenter Studies with Imaging
Moderators: Jon Stoessl and Robert Holloway

A. Logistics and pitfalls of multi-center trials with imaging W. Powers
B. Imaging for diagnosis and natural history studies D. Eidelberg
C. Imaging for drug development J. Seibyl

II. Discussion

1) What are the major pitfalls in using imaging in clinical trials; how does this impact other aspects of the study (recruitment, retention, etc), population based samples?
2) What infrastructure is needed for multi-center studies, how can this be standardized across centers and time (from image acquisition to analysis) given rapidly changing technology?
3) Where is imaging most needed and applicable in PD, diagnostics and natural history studies or therapeutics development (early or efficacy trials)?
4) How does #3 relate to the properties of the tests discussed in previous sections?
10:30 AM Break
10:45-12:45 III. Breakout Groups to Discuss Ligand-Specific Development

What specific applications might each ligand be appropriate for?
What steps/studies are needed to facilitate this over the next 3-5 years?
12:45 PM IV. Working Lunch and Discussion of Breakout Sessions
2:00 PM Adjourn

Last updated February 09, 2005