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NCT04050800 · ClinicalTrials.gov registry record · Early Phase 1
Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety
A Early Phase 1 study, sponsored by Weill Medical College of Cornell University.
- Completed
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
NCT04050800: Completed Early Phase 1 study, sponsored by Weill Medical College of Cornell University.
NCT04050800 is a Early Phase 1 study that has completed, run by Weill Medical College of Cornell University. The registered enrollment target is 5 participants, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04050800, a Early Phase 1 study, has completed, sponsored by Weill Medical College of Cornell University.
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
Study Summary
This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 minutes for two hours. Vital signs (VS), electrocardiograms (ECGs) and clinical laboratory tests of intrernal organ function will be acquired before and at several timepoints after administration of the radiopharmaceutical. Radiation exposures will be estimated with the MIRD Formalism.
Primary Outcome
Fundamental radiation dose quantity in the International Commission on Radiological Protection (ICRP) system of radiological protection. Calculated with OLINDA-EXM software (OLINDA/EXM stands for Organ Level INternal Dose Assessment/EXponential Modeling).
Interventions
- DRUG Carbon 11 Butanol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2020-09-17 |
| Est. Completion | 2021-01-05 |
| Phase | Early Phase 1 |
What the finished NCT04050800 record still lists
NCT04050800 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 53-participant average among 2,764 other Early Phase 1 trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 1 intervention - of which Carbon 11 Butanol is the first listed.
NCT04050800 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04050800 about?
NCT04050800 is a clinical study titled "Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety". This will be a Phase 1, open label, imaging study of radiochemical and radiation safety in healthy volunteers. Using positron emission tomography (PET) and in-line computed tomography (CT), the whole body (WB) biokinetics of Carbon-11 butanol will be quantified with serial scans acquired every 3 min...
What is the current status of trial NCT04050800?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2020-09-17. Estimated completion is 2021-01-05.
What interventions are being tested in trial NCT04050800?
The interventions under investigation include: Carbon 11 Butanol (DRUG).
Who is sponsoring clinical trial NCT04050800?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04050800's enrollment target sits among peer trials
5 1888th of 2000 higher than 80 of 2,000 other Early Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Early 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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