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A continued FDA Concern about Imaging Based Drug Trials

Society of Nuclear MedicineAlbuquerque, 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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-50

-40

-30

-20

-10

0

% Change

1 2

Measurement technique

Percentage Change in the measurement

RECIST Volume

- 3.5 %

- 32 %

baseline

30 days

Diameter = 17.7 mm

Diameter = 17.1 mm

Volume = 886 mm3

Volume = 525 mm3

RECIST vs. Volumetrics

Bensheng Zhao, MSKCC

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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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FDA10903 New Hampshire Ave

Silver Spring, Maryland 20993