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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 Patients With AL or ATTR Systemic Amyloidosis
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.
Details
| Lead sponsor | University of Tennessee Graduate School of Medicine |
|---|---|
| Phase | Phase 1 |
| Status | UNKNOWN |
| Enrolment | 35 |
| Start date | 2023-07 |
| Completion | 2025-12 |
Conditions
- Systemic Amyloidosis
Interventions
- 99mTc-p5+14 is an amyloid reactive peptide labeled with technetium-99m.
- 99mTc-Pyrophosphate and 99mtc-p5+14 - an Amyloid Reactive Peptide Labeled With Technetium-99m.
Primary outcomes
- Whole body effective dosimetry measurement — From enrollment to the end of study is 8 days
Whole body effective radiation dose assessed from analysis of organ-specific radioactivity uptake in planar and SPECT images.
Countries
United States