NCT05625490

Myocardial Perfusion Imaging Galmydar Rest/Stress

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

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 15 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

Summary

A single center, phase 0/1 clinical imaging study designed to assess the role of \[68Ga\]Galmydar PET/CT imaging in human subjects.

Detailed description

The primary objective of the proposed study is to evaluate the potential of \[68Ga\]Galmydar PET/CT myocardial perfusion imaging (MPI) for the noninvasive detection of coronary artery disease. The study will evaluate \[68Ga\]Galmydar PET/CT MPI to semi-quantitatively assess regional myocardial perfusion and quantitatively assess myocardial blood flow (MBF) in patients with suspected or known coronary artery disease (CAD) undergoing clinical SPECT or PET MPI. In addition, perfusion and MBF findings with \[68Ga\]Galmydar will be compared to the results of coronary morphology or stenosis severity in those patients undergoing invasive coronary angiography (ICA) based on abnormal clinical SPECT or PET MPI. The performance of rest/stress \[68Ga\]Galmydar PET/CT in comparison to \[13N\]ammonia PET/CT in normal subjects without cardiovascular disease will be performed as a control. Vital signs, serum chemistries, and serum blood counts will also be obtained.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	Ga-68 Galmydar	Intravenous injections of the PET radiotracer \[68Ga\]Galmydar.
DRUG	13N-ammonia	Two intravenous injections of PET radiotracer \[13N\]Ammonia.

Timeline

• Start date: 2022-11-11
• Primary completion: 2025-12-17
• Completion: 2025-12-19
• First posted: 2022-11-23
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study