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NCT01433705 · ClinicalTrials.gov registry record · Phase 1
Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 70
- Enrollment target
NCT01433705: Completed Phase 1 study, sponsored by University of Michigan.
NCT01433705 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 70 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01433705, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 70 participants
- Enrollment target
Study Summary
Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease. Normal healthy volunteers will be carefully screened for this study. Subjects will be given IV administration of Rb-82 and N-13 to acquire rest/stress imaging. Normal subjects not excluded by any unexpected abnormality during the Rb-82 or N-13 rest/stress studies will undergo a glucose loading F-18 FDG imaging protocol, viability protocol using the hyperinsulinemic euglycemic clamp with simultaneous IV infusions of dextrose and insulin according to standard procedures in our laboratory. These same subjects will have a F-18 FDG protocol after following a high fat, protein permitted, no carbohydrate diet for approximately 30 hours prior to F-18 FDG injection. The F-18 FDG radiotracer will be given through an IV.
Primary Outcome
Normal healthy volunteers will undergo PET imaging during vasodilator pharmacologic stress with regadenoson and at rest with Rb-82 and or N-13 ammonia and or at rest with F-18FDG. Participants will have either rest and stress Rb-82 and rest and stress N-13 ammonia or one of these stress tests and F-18 FDG imaging.
Interventions
- DRUG Regadenoson
- OTHER Rb-82 Pet scans
- OTHER F-18 FDG Pet scans
- OTHER N-13 ammonia Pet scans
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 70 participants |
| Start Date | 2011-11 |
| Est. Completion | 2018-01-19 |
| Phase | Phase 1 |
What the finished NCT01433705 record still lists
NCT01433705 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 70 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (17% higher).
The record links to 0 conditions, and to 4 interventions - of which Regadenoson is the first listed.
NCT01433705 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01433705 about?
NCT01433705 is a clinical study titled "Distribution of Rubidium-82, Nitrogen-13 Ammonia, and Fluorine-18 Fluorodeoxyglucose in Normal Volunteers". Establish the normal distributions of Rb-82, N-13 ammonia, and F-18 FDG (radioactive tracers) in the heart using PET imaging. These tracers would be eventually used in evaluating the hearts of patients with heart disease. Normal healthy volunteers will be carefully screened for this study. Subjects...
What is the current status of trial NCT01433705?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 70 participants. The study started on 2011-11. Estimated completion is 2018-01-19.
What interventions are being tested in trial NCT01433705?
The interventions under investigation include: Regadenoson (DRUG), Rb-82 Pet scans (OTHER), F-18 FDG Pet scans (OTHER), N-13 ammonia Pet scans (OTHER).
Who is sponsoring clinical trial NCT01433705?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01433705's enrollment target sits among peer trials
70 749th of 2000 higher than 1,227 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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