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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: Completed Phase 1 study, sponsored by University of Tennessee Graduate School of Medicine.
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, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Localization of 124I-p5+14 will be taken from PET/CT images performed at intervals during the 48 hours after injection. Organ-specific dosimetry and whole body dose measurements will be made using Olinda software (Olinda/Exp; Organ Level Internal Dose Assessment/Exponential Modeling)
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 |
What the finished NCT03678259 record still lists
NCT03678259 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 57 participants, a relatively small participant target, roughly in line with the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target.
The record links to 0 conditions, and to 1 intervention - of which 124I-p5+14 Injection is the first listed.
NCT03678259 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03678259's enrollment target sits among peer trials
57 901st of 2000 higher than 1,099 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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