NCT04050800

Carbon-11 Butanol: Whole Body Radiochemical and Radiation Safety

Characterizing the Safety of [Carbon-11]Butanol and Estimating the Test-Retest Variance in Measurements of Its Whole Body Biokinetics Under Zero-Biological-Change Conditions

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Weill Medical College of Cornell University · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Accepted

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.

Detailed description

Vital signs (VSs) will be measured, electrocardiograms (ECGs) will be acquired, and blood will be sent to the clinical laboratory for safety assessments before a single dose, intravenous (IV) administration of 555 MBq of Carbon-11 butanol. VSs will be re-measured, ECGs will be acquired again, and more blood will be sent to the clinical laboratory for repeat safety assessments after 2 hours of whole body (WB) scanning. WB scanning will consist of imaging acquisition sweeps of 200 cm from head-to-toe over 180 secs (3 min). Up to 40 sweeps per imaging session will be performed. The subjects will then be given a rest period ("coffee break") for about two hours, after which the entire sequence of events will be repeated. The primary outcome measure will be related to radiation safety derived from the areas under the time-activity curves (AUCs) for internal organs. Co-primary clinical safety measures will include changes in VSs, ECG parameters such as the PR and corrected QT intervals, and clinical laboratory tests, such as proteins that reflect renal and hepatic function. Secondary endpoints will include the time-activity curves (TACs) and total volumes of distribution (VT) in several brain regions. The results should allow calculation of the repeatability coefficients (RCs) under zero-biological-change conditions. RC values will be essential for understanding whether future measurements of effect sizes in response to therapeutic maneuvers or the differences between groups are meaningful.

Conditions

• Neuro-Degenerative Disease

Interventions

Type	Name	Description
DRUG	Carbon 11 Butanol	Two sequential administrations of a PET tracer

Timeline

• Start date: 2020-09-17
• Primary completion: 2020-12-29
• Completion: 2021-01-05
• First posted: 2019-08-08
• Last updated: 2021-06-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study