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Description and implementation of a quality control program in an imaging-based clinical trial
Christopher H Cagnon1, Dianna D Cody, Michael F McNitt-Gray
1Department of Radiological Sciences, David Geffen School of Medicine at UCLA, BH-427D, CHS, 10833 LeConte Avenue, Los Angeles, CA 90095-1721, USA.
Academic Radiology
|November 23, 2006
Summary
A quality control program was developed for the National Lung Screening Trial to standardize imaging protocols and equipment for multidetector helical computed tomography (MDCT) and chest radiography (CXR) in lung cancer screening.
Area of Science:
- Radiology
- Medical Imaging
- Oncology
Background:
- The National Lung Screening Trial (NLST) compares multidetector helical computed tomography (MDCT) and chest radiography (CXR) for lung cancer screening.
- Image quality is crucial for detecting disease and tracking suspicious findings in clinical trials.
Purpose of the Study:
- To develop a comprehensive image quality control (QC) program for all participating clinical sites in the NLST.
- To ensure consistent and standardized imaging protocols and equipment performance for both MDCT and CXR modalities.
Main Methods:
- Established minimum equipment standards and standardized cross-platform acquisition protocols through radiologist and physicist attestation and web-distributed technique charts.
- Implemented an initial machine certification process including equipment calibration.
- Instituted ongoing assessment via periodic submission of calibration records and phantom images, with participant data entered into a centralized database for protocol variation flagging.
- A radiologist visual review committee evaluated diagnostic image quality.
Main Results:
- Identified and addressed widespread variations in imaging protocols, equipment technology, acquisition parameters, and user interfaces across 23 centers and multiple scanner models.
- Refined acceptable ranges for image acquisition parameters to accommodate evolving equipment and diverse participant characteristics.
Conclusions:
- Standardization of imaging protocols is essential for image-based clinical trials.
- Continuous dialogue between participating sites and a centralized review committee is fundamental for successful image QC.
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