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

The Washington University

Status and phase: Completed; Early Phase 1

Conditions: Coronary Artery Disease

Treatments: Drug: Ga-68 Galmydar

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05280782

202107042

IND 157468 (Other Identifier)

R01HL142297 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This study is a single center, early phase 1 clinical imaging study designed to assess the dosimetry of 68Ga-Galmydar for PET/CT imaging.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy men and women, 18-99 years of age and any race

Exclusion criteria

• 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

8 participants in 1 patient group

Dosimetry Group

Experimental group

Description:

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.

Treatment:

Drug: Ga-68 Galmydar