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NCT03678259 · ClinicalTrials.gov registry record · Phase 1
124I-p5+14 Injection Safety in Subjects With Systemic Amyloidosis
A Phase 1 study, sponsored by University of Tennessee Graduate School of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 57
- Enrollment target
NCT03678259 is a Phase 1 study that has completed, run by University of Tennessee Graduate School of Medicine. The registered enrollment target is 57 participants.
The verdict
NCT03678259, a Phase 1 study, has completed, sponsored by University of Tennessee Graduate School of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 57 participants
- Enrollment target
Study Summary
This is a single-center, exploratory, Phase 1 Positron Emission Tomography/x-ray Computed Tomography (PET/CT) imaging study to detect amyloidosis that will enroll patients with a confirmed diagnosis of systemic amyloidosis. The purpose of this exploratory trial is to assess the safety and efficacy of 124I-p5+14 Injection at a single-injection dose adequate for imaging amyloid deposits by using PET/CT imaging in subjects with confirmed systemic Immunoglobulin Light Chain-associated Amyloidosis (AL), Transthyretin-associated Amyloidosis (ATTR), Leukocyte Chemotactic Factor 2-associated Amyloidosis (ALect2) as well as other types.
Interventions
- DRUG 124I-p5+14 Injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2018-10-01 |
| Est. Completion | 2021-10-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03678259
The ClinicalTrials.gov registry entry for NCT03678259 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Tennessee Graduate School of Medicine, which has 20 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which 124I-p5+14 Injection is the first listed.
NCT03678259 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03678259 about?
NCT03678259 is a clinical study titled "124I-p5+14 Injection Safety in Subjects With Systemic Amyloidosis". This is a single-center, exploratory, Phase 1 Positron Emission Tomography/x-ray Computed Tomography (PET/CT) imaging study to detect amyloidosis that will enroll patients with a confirmed diagnosis of systemic amyloidosis. The purpose of this exploratory trial is to assess the safety and efficacy o...
What is the current status of trial NCT03678259?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 57 participants. The study started on 2018-10-01. Estimated completion is 2021-10-01.
What interventions are being tested in trial NCT03678259?
The interventions under investigation include: 124I-p5+14 Injection (DRUG).
Who is sponsoring clinical trial NCT03678259?
This trial is sponsored by University of Tennessee Graduate School of Medicine, which has 20 total clinical trials registered on ClinicalTrials.gov.
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