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

Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL

Official Title: Phase 1 Study to Investigate the Dosimetry and Biodistribution of a Single Intravenous Administration of 99mTc-p5+14 Using SPECT/CT Imaging and Planar Gamma Scintigraphy in Healthy Volunteers and

Brief Summary: This study will investigate 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for detecting paamyloid deposits in patients with AL or ATTR-associated systemic amyloidosis, notably with cardiac involvement.

Detailed Summary: The University of Tennessee Graduate School of Medicine (UTGSM) is investigating 99mTc-p5+14, an amyloid-reactive synthetic peptide, p5+14, radiolabeled with technetium-99m, as a radiotracer for planar gamma scintigraphy (PGS), single photon emission computed tomography (SPECT) or SPECT with x-ray computed tomography (SPECT/CT) for the diagnosis of systemic amyloidosis, notably with cardiac involvement.
Based on nonclinical data and clinical data of 124I-p5+14 from Study AMY1001, peptide p5+14 binds many types of human amyloid and is rapidly cleared from the central compartment.
When radiolabeled with 99mTc, p5+14 may enable visualization of amyloid laden tissues and organs by SPECT/CT imaging or PGS.
Thus, this study has been designed to evaluate the dosimetry and biodistribution of 99mTc-p5+14 in patients with systemic amyloidosis compared with the biodistribution in healthy volunteers.
Sponsor: University of Tennessee Graduate School of Medicine

Current Primary Outcome: Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.

Original Primary Outcome: Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Tennessee Graduate School of Medicine

Dates:
Date Received: June 30, 2023
Date Started: July 01, 2023
Date Completion: July 01, 2023
Last Updated: July 10, 2023
Last Verified: July 01, 2023