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

Early Phase 1

Completed

Conditions: Coronary Artery Disease

Interventions: Drug: Ga-68 Galmydar

Registration Number: NCT05280782

Lead Sponsor: Washington University School of Medicine

Brief 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 8

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dosimetry Group	Ga-68 Galmydar	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.

Primary Outcome Measures

Name	Time	Method
Organ Dosimetry	6 hours from 68Ga-Galmydar injection	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.
Biodistribution	6 hours from 68Ga-Galmydar injection	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.
Total Effective Dose of the Radiotracer	6 hours from 68Ga-Galmydar injection	Total Effective Dose of the radiotracer is calculated using ICRP-60 organ weights and is reported in rem/mCi.

Secondary Outcome Measures

Name	Time	Method
Clinically Significant Change in Respiratory Rate.	6 hours from 68Ga-Galmydar injection	A respiratory rate of \< 12 or \> 20 breaths/min.
Clinically Significant Elevation in Oral Temperature	6 hours from 68Ga-Galmydar injection	Oral temperature of \>100 degrees F.
Clinically Significant Change in White Blood Cell Count (WBC)	6 hours from 68Ga-Galmydar injection	White blood cell count measured in WBC/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Mean Corpuscular Volume (MCV)	6 hours from 68Ga-Galmydar injection	MCV measured in µm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in EKG Showing New AV Block	6 hours from 68Ga-Galmydar injection	A change in EKG showing new AV Block (Type 1 or Type 2), Mobitz 2:1, or QTc ≥ 500ms).
Clinically Significant Change in Platelets	6 hours from 68Ga-Galmydar injection	Platelets measured in platelets/mm3 blood. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Red Blood Cell Count (RBC)	6 hours from 68Ga-Galmydar injection	RBC measured in million/mm3. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Blood Pressure.	6 hours from 68Ga-Galmydar injection	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.
Clinically Significant Change in Heart Rate.	6 hours from 68Ga-Galmydar injection	A heart rate of \< 50 BPM or \> 100 or a 20 BPM change from baseline.
Clinically Significant Change in EKG Showing New Bradycardia	6 hours from 68Ga-Galmydar injection	New heart rate \< 40 BPM.
Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin	6 hours from 68Ga-Galmydar injection	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.
Clinically Significant Change in Hematocrit (Hct)	6 hours from 68Ga-Galmydar injection	Hct measured in %. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2	6 hours from 68Ga-Galmydar injection	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.
Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.	6 hours from 68Ga-Galmydar injection	Serum chemistries (total protein, albumin), measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST	6 hours from 68Ga-Galmydar injection	Serum chemistries (alkaline phosphatase), measured in U/L. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.
Clinically Significant Change in Hemoglobin (Hgb)	6 hours from 68Ga-Galmydar injection	Hgb measured in g/dL. Values outside of laboratory range in comparison to baseline or \>20% difference from baseline values.