Early Phase 1
N=8
Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT05280782 ↗Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Sep 2023
Primary outcome: Primary: Organ Dosimetry — 0.109; 0.019; 0.012; 0.034 rad/mCi
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Ga-68 Galmydar (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Washington University School of Medicine
- Primary completion
- May 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Organ Dosimetry |
0.109; 0.019; 0.012; 0.034; 0.018; 1.923 | — |
| PRIMARY Biodistribution |
1.923 | — |
| PRIMARY Total Effective Dose of the Radiotracer |
0.103 | — |
| SECONDARY Clinically Significant Change in Blood Pressure. |
8; 0; 8; 0; 8; 0 | — |
| SECONDARY Clinically Significant Change in Heart Rate. |
8; 0; 8; 0 | — |
| SECONDARY Clinically Significant Change in Respiratory Rate. |
8; 0; 7; 1 | 0.016 sig |
| SECONDARY Clinically Significant Elevation in Oral Temperature |
8; 0; 8; 0 | — |
| SECONDARY Clinically Significant Change in EKG Showing New AV Block |
8; 0; 8; 0 | — |
| SECONDARY Clinically Significant Change in EKG Showing New Bradycardia |
8; 0; 8; 0 | — |
| SECONDARY Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 |
8; 0; 5; 0; 8; 0 | 0.219 |
| SECONDARY Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin |
7; 1; 4; 1; 7; 1 | 0.375 |
| SECONDARY Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. |
8; 0; 5; 0; 7; 1 | 0.219 |
| SECONDARY Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST |
8; 0; 5; 0; 7; 1 | 0.219 |
| SECONDARY Clinically Significant Change in White Blood Cell Count (WBC) |
6; 2; 4; 1 | 0.687 |
| SECONDARY Clinically Significant Change in Hemoglobin (Hgb) |
7; 1; 4; 1 | 0.375 |
| SECONDARY Clinically Significant Change in Hematocrit (Hct) |
6; 2; 2; 3 | 1.000 |
| SECONDARY Clinically Significant Change in Platelets |
8; 0; 5; 0 | — |
| SECONDARY Clinically Significant Change in Red Blood Cell Count (RBC) |
7; 1; 4; 1 | 0.375 |
| SECONDARY Clinically Significant Change in Mean Corpuscular Volume (MCV) |
8; 0; 5; 0 | — |
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 Criteria
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 40 kg/m2.
Data sourced from ClinicalTrials.gov (NCT05280782). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.