Status:
COMPLETED
Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Lead Sponsor:
Washington University School of Medicine
Collaborating Sponsors:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
Brief 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.
Detailed Description
The objective is to evaluate dosimetry, biodistribution, safety, and imaging characteristics following a single 68Ga-Galmydar injection in normal healthy volunteers. Healthy adult normal volunteers (n...
Eligibility Criteria
Inclusion
- • Healthy men and women, 18-99 years of age and any race
Exclusion
- Inability to receive and sign informed consent;
- Positive urine screen for drugs of abuse at screening or before dosing or over-the- counter drug use or herbal preparations within the 2-week period prior to enrollment;
- Participation in another research study with a study drug, including a diagnostic or therapeutic radiopharmaceutical, to be administered during this study or which was or will be administered within 10 hall-lives of the radiopharmaceutical.
- Severe claustrophobia;
- Pregnant or breastfeeding.
- Body mass index \< 18 kg/m2 or \> 40 kg/m2.
Key Trial Info
Start Date :
January 5 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05280782
Start Date
January 5 2022
End Date
May 1 2022
Last Update
September 8 2023
Active Locations (1)
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1
Washington University School of Medicine
St Louis, Missouri, United States, 63110