Joint Fellowship Training Program
Mentor:
Kyle J. Myers, Ph.D.
Organizational Affiliation and Position:
Laboratory Leader, Medical Imaging and Diagnostics Laboratory, Division of Imaging and Applied Mathematics (DIAM), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), FDA
Email:
kyle.myers@fda.hhs.gov
Phone:
301-443-3314 ext. 150
Running Title of Program:
Quantitative Imaging as a Surrogate Marker for Drug Trials
Research Project Summary:
The imaging program in the Division of Imaging and Applied Mathematics (DIAM), Office of Science and Engineering Laboratories (OSEL), Center for Devices and Radiological Health (CDRH), FDA, has a well-established reputation in the field of performance assessment of medical imaging systems and ancillary devices such as computer aided diagnostic algorithms. It is also fully integrated within the Center regulatory review process for these devices.
As volumetric imaging has become more and more sophisticated and important to the diagnostic process, DIAM scientists have increasingly turned their attention to this area. However, much of their work has centered on the "detection" problem, the question of whether or not a lesion is present in a particular image. At the present time there is a requirement to further investigate the "estimation" problem, one aspect of which is the question of accurate measurement of lesion volume. In pursuit of these goals DIAM has collaborated closely with the NCI Lung Imaging Database Consortium (LIDC) and its extension with the Reference Image Database to Evaluate Response (RIDER) project and has formed a joint laboratory with NIBIB. This latter project is intimately related to the effort by FDA's Center for Drug Evaluation and Research (CDER) to examine the use of images as surrogate markers for the effectiveness of drug therapy.
Proposed project for IOTF fellow:
The Fellow will collaborate with DIAM staff in investigating the morphology of lesions and the surrounding anatomy, modeling and simulating the image formation process with realistic lesions and anatomy, characterizing the statistical properties of the subsequent images, deriving likelihood functions that relate parameters describing lesions and anatomy to the image statistics, using the likelihood functions to developing assessment methods for volume estimators, and designing new volume estimators. The Fellow will apply these methods to the RIDER database images.
Regulatory Activity:
The Fellow will gain experience with the device approval process used in CDRH and the drug approval process in CDER through exposure to computer-aided diagnosis (CAD) device and drug applications. This will involve understanding how CDRH and CDER performs its premarket and postmarket functions and the importance of risk management in evaluating the safety of new medical products.
Reference(s):
Barrett HH, Myers KJ. Foundations of Image Science, John Wiley & Sons, Inc., New York, 2004.
Dodd LE, Wagner RF, Armato SG, McNitt-Gray MF, Beiden S, Chan HP, Gur D, McLennan G, Metz CE, Petrick N, Sahiner B, Sayre J, "Assessment methodologies and statistical issues for computer-aided diagnosis of lung nodules/
