Transcript Slide 1

A continued FDA Concern about
Imaging Based Drug Trials
Society of Nuclear Medicine
Albuquerque, Feb 1-2, 2009
Orhan H Suleiman MS PhD, FAAPM
Senior Science Policy Adviser
Office of Oncology Drug Products
Office of New Drugs
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Good science!
Good scientific principles are essential for
good imaging based trials:
1. Standardize imaging equipment;
2. standardize imaging acquisition, processing, and
display protocol;
3. standardize readers.
4. Know the uncertainties- 1%, 5%, 20%, 50%, 100%, ?
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In order to detect change clinically, you need to
assure the standard image remains constant.
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Conduct Quality Control Testing
In order to assure that the images are being
produced consistently over time you should…
Quality control test, with a phantom, before,
during, and at the end of the trial, which should
assure consistency in equipment performance!
This includes the use of the same software
and imaging technique.
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History of Imaging Criteria
World Health Organization (1970’s)
Response Evaluation Criteria in Solid
Tumors – RECIST (2000, 2008)
3-dimensional volumetric analysis (current)
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RECIST vs. Volumetrics
baseline
Diameter = 17.7 mm
Volume = 886 mm3
30 days
Diameter = 17.1 mm
Volume = 525 mm3
Percentage Change in the measurement
0
-10
% Change
- 3.5 %
-20
-30
-40
- 32 %
-50
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Bensheng Zhao, MSKCC
RECIST
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Volume
Measurement technique
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“Calibrate” Human Readers
Train the qualified readers, prospectively!
Use standard images to “calibrate” readers, either
physically together, or with a detailed protocol. This
should minimize adjudication.
Protocol should specify data collection, viewing
conditions, image scoring and other criteria.
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In closing…
Quality control testing with appropriate test
phantoms must be used on all imaging
equipment used to generate clinical images
during the trial.
Ultimately successful clinical trials depend on
using good science for the entire trial (drug,
equipment, image, analysis).
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FDA
10903 New Hampshire Ave
Silver Spring, Maryland 20993
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