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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Drug: Ga-68 Galmydar


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dosimetry Group<br>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. | Drug: Ga-68 Galmydar<br>* Single intravenous injection of the PET radiotracer 68Ga-Galmydar.<br>* Other names: IND 157468;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Organ Dosimetry | On whole body PET/CT, regions of interest are drawn on the liver, spleen, kidney, lumbar vertebrae and left ventricle of the heart. Average organ dose is measured and compared. Organ radiation dose is measured and reported in rad/mCi. | 6 hours from 68Ga-Galmydar injection | 
| Biodistribution | The organ with the highest radiation dose in rad/mCi is determined to be the dose-critical organ. The organ showing the largest dose is the gallbladder wall. | 6 hours from 68Ga-Galmydar injection | 
| Total Effective Dose of the Radiotracer | Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi. | 6 hours from 68Ga-Galmydar injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Significant Change in Blood Pressure. | The following variables are considered clinically significant if changes occur from baseline. A systolic BP of < 90 or > 160 mmHg or a diastolic BP of < 50 or > 100 mmHg or a 20 mmHg change from baseline in the SBP or DBP. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Heart Rate. | A heart rate of < 50 BPM or > 100 or a 20 BPM change from baseline. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Respiratory Rate. | A respiratory rate of < 12 or > 20 breaths/min. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Elevation in Oral Temperature | Oral temperature of >100 degrees F. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in EKG Showing New AV Block | A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms). | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in EKG Showing New Bradycardia | New heart rate < 40 BPM. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2 | Serum chemistries (sodium, potassium, chloride, CO2) measured in mmol/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin | Serum chemistries (glucose, calcium creatinine, BUN, total bilirubin), measured in mg/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Serum Chemistries: Total Protein, Albumin. | Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST | Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in White Blood Cell Count (WBC) | White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Hemoglobin (Hgb) | Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Hematocrit (Hct) | Hct measured in %. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Platelets | Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Red Blood Cell Count (RBC) | RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 
| Clinically Significant Change in Mean Corpuscular Volume (MCV) | MCV measured in µm3. Values outside of laboratory range in comparison to baseline or >20% difference from baseline values. | 6 hours from 68Ga-Galmydar injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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myocardial perfusion imaging, pharmacological stress, biodistribution, positron emission tomography, myocardial blood flow