Study of 18FFT8 PETCT Imaging to Diagnose and Evaluate Cardiac and Systemic Amyloidosis

What this Trial Is About

Researchers are evaluating the use of 18FFT8, a diagnostic imaging agent, for detecting amyloidosis, including cardiac amyloidosis. This study aims to assess the safety and effectiveness of 18FFT8 PETCT scans in visualizing AL amyloid deposits in the heart, comparing its performance to established clinical methods such as echocardiography, MRI, and laboratory tests. The goal is to establish a reliable PET imaging protocol for direct diagnosis and differentiation of AL amyloidosis. Participants will receive a single intravenous injection of 10 b1 3 mCi of 18FFT8, followed by a PETCT scan to measure organ uptake using the standardized uptake value SUV. The study includes both healthy volunteers and amyloidosis patients. The imaging and injection occur only once, and no additional treatments are administered. Clinical assessments and lab tests are done before and after the scan to monitor safety and gather diagnostic information. During the study, participants will undergo physical exams, cardiac function assessments, and tests of liver and kidney function before and after the PETCT scan. Researchers will monitor safety from the time of injection up to seven days afterward, and evaluate organ uptake and biodistribution of 18FFT8 at the time of the scan. Radiation exposure is also measured. Total participation involves a single visit for imaging and assessments, with follow-up safety monitoring over one week.

[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis