Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass

EARLY_PHASE1CompletedINTERVENTIONAL
Enrollment

23

Participants

Timeline

Start Date

July 2, 2013

Primary Completion Date

April 23, 2014

Study Completion Date

April 23, 2014

Conditions
Healthy VolunteersDiabetes Mellitus, Type 1
Interventions
DRUG

18 F-FP-DTBZ

The drug, no carrier added \[18 F\]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce \[18 F\]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 millicuries (mCi) of \[18 F\]-FP-DTBZ for injection immediately prior to imaging. The specific activity at time of injection will less than 1.0 mCi/microgram and thus for a 7.6 mCi dose the maximal mass dose will be less than 10 microgram.

RADIATION

PET Scanning

Individuals will be imaged continuously (i.e. dynamically) for 2 hours.

Trial Locations (1)

10032

Naomi Berrie Diabetes Center, New York

All Listed Sponsors
collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

lead

Columbia University

OTHER

NCT02236754 - Evaluation of 18 F-FP-DTBZ Pancreatic PET Scanning as a Tool to Measure Beta Cell Mass | Biotech Hunter | Biotech Hunter