Imaging Endpoints Provides Guidance Related to Global Contrast Shortage for Radiologic Assessment in Clinical Trials
June 2, 2022 – Due to the recent COVID-19-related shutdown of a factory in Shanghai, there is a nationwide shortage of intravenous iodinated contrast media (e.g., iohexol) which is expected to last for several more weeks. As a consequence of the shortage, physicians and patients are concerned about the potential impact on cancer care, especially oncology patients enrolled in clinical trials who require frequent imaging visits. At Imaging Endpoints, we have applied an imaging strategy that provides support for continued radiologic assessment of participants in clinical trials with minimum disruption in the continuity of care, and acceptable imaging acquisition alternatives for disease staging and response assessments. Some of these acquisition alternatives are listed below:
- Non-contrast enhanced CT of the chest with a contrast-enhanced MRI of the abdomen and pelvis to allow for reliable tumor size measurements for disease response and progression assessments
- Non-contrast enhanced CT of the chest with a non-contrast enhanced MRI of the abdomen and pelvis which allows for surveillance of disease progression assessments
- Non-contrast enhanced CT of the chest abdomen and pelvis which allows for disease progression based on potential new lesion detection and gross changes in tumor growths
- For hematologic malignancies, FDG PET remains the mainstay of response assessments in FDG Avid tumor types and is impacted less by the current IV contrast shortage than are solid tumors
Alternatives, such as ultrasound, are not recommended in clinical trials because the examination is operator dependent and full examinations cannot be reproducibly performed for independent review. If an inconsistency in imaging technique occurs during the trial, our Imaging Review Charters (IRCs) generally allow for the applicable options above and for expert reviewers to use their best medical judgment and knowledge of tumor measurements to reduce the number of non-evaluable time points. Once the IV CT contrast shortage resolves, patients should return to their normal imaging schedules. Please Contact Us to discuss the applicable IRC language and options available for your trial.
