Year: 2006
Type: article
Abstract: Inclusion of imaging studies in clinical trials poses added challenges. Uniform methods for identifying and tracking protocol deviations and adverse events are well established, but do not account for many logistical and technical problems that can affect image quality and trial success. These “technical” deviations may not be apparent to study coordinators and often are identified only when images are processed. To classify and evaluate the frequency and types of technical deviations in a multi–center imaging trial of patients with suspected frontotemporal dementia using positron emission tomography with 18F–fluorodeoxyglucose (FDG–PET). Nine academic centers with variable experience using FDG–PET in research and clinical care performed 55 scans and sent data to a centralized data coordinating center (DCC) for analysis. Scans were performed using standard techniques that did not involve head or body restraints. History of a behavior disturbance was not exclusionary; indeed it was common in these patients. We monitored the completion of studies, including timeliness of data transfer and processing. Images received at the DCC were evaluated against established quality standards. Deviations from expectations were classified into six categories and rated for severity based upon their effect on final image quality. 52 of 55 images (96%) ultimately met full quality standards and all but one scan obtained early in the study were usable. There were 4 acquisition and 10 processing deviations and 1 HIPAA violation. The most frequent technical deviation was a delay in transferring data to the DCC. There were no cases of poor image quality from subject movement. The number of technical deviations was variable from site to site and became less frequent as the trial progressed. The DCC identified one unexpected incidental image abnormality. Uniform and comprehensive technical standards should be established at the onset of imaging trials and assessed prospectively using explicit rules. Our procedures are effective and could be widely adopted. Timely quality assessment and working closely with sites can minimize problems caused by technical deviations. High quality FDG–PET studies can be achieved without restraints, even in demented patients with a history of behavior disturbance.
Source: Alzheimer s & Dementia
Authors: Norman L. Foster, Robert A. Koeppe, Judith L. Heidibrink, Valerie Stevenson, Carol VanHuysen, Pilot Collaborative PET Imaging Trial
Institutions: University of Utah, University of Michigan
Language: English
Subfield: Radiology, Nuclear Medicine and Imaging
Field: Medicine
Domain: Health Sciences
Open Access status: bronze
OpenAlex ID: W4206350610