Phase 1 Study of 99mTc-p514 Imaging for Detecting Systemic Amyloidosis with Cardiac Involvement in Healthy Volunteers and Patients

What this Trial Is About

Researchers are evaluating 99mTc-p514, a synthetic peptide labeled with technetium-99m, as a radiotracer for detecting amyloid deposits in patients with AL or ATTR systemic amyloidosis, particularly those with heart involvement. This phase 1 study aims to assess how the tracer distributes in the body and the radiation dose it delivers compared to healthy volunteers. The study builds on previous findings showing that the peptide binds to amyloid and clears quickly from the bloodstream, potentially allowing detailed imaging of affected tissues using specialized scans. Participants include healthy volunteers and patients diagnosed with systemic amyloidosis. They will receive a single intravenous dose of 99mTc-p514, followed by a series of imaging scans planar scintigraphy and SPECTCT at various time points up to 24 hours post-injection. Patients will also undergo a comparison imaging procedure using 99mTc-Pyrophosphate to evaluate heart amyloid deposits. Blood samples, vital signs, ECGs, and echocardiograms will be collected at specified times during the study. Throughout the approximately 8-day study period, participants will have multiple imaging sessions and clinical assessments to monitor tracer distribution and radiation exposure. The main measurement is whole body effective dosimetry. Researchers will also measure tracer uptake in the heart and other tissues. Safety monitoring includes vital signs and heart function tests. The study involves a brief outpatient schedule with imaging and blood sampling to support diagnosis improvement for systemic amyloidosis.

A Phase 1 Study of 99mTc-p5+14 in Healthy Volunteers and Patients With AL or ATTR Systemic Amyloidosis