NCT05280782

Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group

Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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=8, 4 males; 4 females) will undergo whole-body imaging (dosimetry group). Healthy adult normal volunteers (n=8, 4 males; 4 females) will receive a single intravenous Ga-68 Galmydar administration of 8 mCi ± 20% (6.4-9.6 mCi) with a mass of ≤ 10 µg followed by whole-body PET/CT imaging.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ga-68 Galmydar	Single intravenous injection of the PET radiotracer 68Ga-Galmydar.

Timeline

• Start date: 2022-01-05
• Primary completion: 2022-05-01
• Completion: 2022-05-01
• First posted: 2022-03-15
• Last updated: 2023-09-08
• Results posted: 2023-09-08

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study