Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging
Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY
This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: t
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• • Healthy men and women, 18-99 years of age and any race
Locations
United States
Missouri
Washington University School of Medicine
Saint Louis
Time Frame
Start Date: 2022-01-05
Completion Date: 2022-05-01
Participants
Target number of participants: 8
Treatments
Experimental: Dosimetry Group
Normal Volunteers will receive a single intravenous injection of 8 mCi ± 20% (6.4-9.6 mCi) of the PET radiotracer 68Ga-Galmydar. They will undergo whole-body PET/CT imaging at three-time points, immediately post \[68Ga\]Galmydar injection, and at 2 hours and 4 hours after injection. Serum chemistries, complete blood count, EKG, vital signs, and physical examination will performed before injection and at the completion of the examinations.
Authors
Related Therapeutic Areas
Sponsors
Leads: Washington University School of Medicine
Collaborators: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)