Development and Implementation of a Radiation Safety Screening Protocol for a Clinical Study Using Amyloid Positron...

Area of Science:

• Medical Imaging
• Radiology
• Clinical Trials

Background:

• Amyloid PET imaging is increasingly used in clinical and research settings, especially with new anti-amyloid therapies.
• While clinical benefits of PET outweigh radiation risks, elective radiation exposure in research requires careful consideration.
• Existing guidelines lack criteria for prior radiation exposure in clinical trial eligibility.

Purpose of the Study:

• To address the lack of guidelines for prior radiation exposure in clinical trials involving amyloid PET.
• To develop and implement a systematic safety screening procedure for estimating cumulative radiation exposure.

Main Methods:

• Literature review of radiation safety criteria and protocols for amyloid PET studies on ClinicalTrials.gov.
• Development of a novel safety screening procedure to estimate prior radiation exposure.
• Implementation of the screening procedure in the Successful AGing after Elective Surgery (SAGES) study.

Main Results:

• Only 1% of 92 reviewed amyloid PET studies on ClinicalTrials.gov had specific radiation exclusion criteria.
• 37% of studies did not report screening for prior radiation exposure.
• The developed screening protocol deemed 17% of 101 participants ineligible for an amyloid PET substudy due to prior radiation exposure.

Conclusions:

• A systematic, standardized screening protocol for prior radiation exposure is essential for clinical studies.
• Implementing such protocols minimizes participant risk in studies involving elective radiologic procedures.
• This approach enhances safety in research involving ionizing radiation.