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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 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 70 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01433705
The ClinicalTrials.gov registry entry for NCT01433705 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 4 interventions - of which Regadenoson is the first listed.
NCT01433705 reports 0 study locations.
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.
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