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NCT01815086 · ClinicalTrials.gov registry record · Phase 1
Radioimmunoimaging of Light Chain (AL) Amyloidosis
A Phase 1 study, sponsored by University of Tennessee.
- Completed
- Registry status
- Phase 1
- Development phase
- 30
- Enrollment target
NCT01815086: Completed Phase 1 study, sponsored by University of Tennessee.
NCT01815086 is a Phase 1 study that has completed, run by University of Tennessee. The registered enrollment target is 30 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01815086, a Phase 1 study, has completed, sponsored by University of Tennessee.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 30 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
Primary Outcome
PET/CT images will be taken 2 and 5 days post-radiolabeled antibody infusion to evaluate if there is organ/tissue uptake (greater than blood pool) and to determine if the presence of radiolabeled antibody correlates with clinically proven amyloid deposition.
Interventions
- BIOLOGICAL Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2008-12 |
| Est. Completion | 2013-07 |
| Phase | Phase 1 |
What the finished NCT01815086 record still lists
NCT01815086 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (50% lower).
The record links to 0 conditions, and to 1 intervention - of which Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) is the first listed.
NCT01815086 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01815086 about?
NCT01815086 is a clinical study titled "Radioimmunoimaging of Light Chain (AL) Amyloidosis". The purpose of the study is to determine the capability of a radiolabeled amyloid-reactive monoclonal antibody (mAb) to document the presence and distribution of amyloid deposits by PET/CT imaging in patients with AL amyloidosis.
What is the current status of trial NCT01815086?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 30 participants. The study started on 2008-12. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01815086?
The interventions under investigation include: Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg) (BIOLOGICAL).
Who is sponsoring clinical trial NCT01815086?
This trial is sponsored by University of Tennessee, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01815086's enrollment target sits among peer trials
30 1332nd of 2000 higher than 561 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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