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

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

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

Study Overview

• Status: Completed
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Drug: Ga-68 Galmydar

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Dosimetry Group; 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; Single intravenous injection of the PET radiotracer 68Ga-Galmydar.; Other Names: IND 157468

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Pamela K Woodard, M.D., Washington University School of Medicine

Publications and helpful links

General Publications

• Sivapackiam J, Laforest R, Sharma V. 68Ga[Ga]-Galmydar: Biodistribution and radiation dosimetry studies in rodents. Nucl Med Biol. 2018 Apr;59:29-35. doi: 10.1016/j.nucmedbio.2017.11.008. Epub 2017 Dec 1.

Study record dates

Study Major Dates

• Study Start (Actual): January 5, 2022
• Primary Completion (Actual): May 1, 2022
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: January 18, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 15, 2022

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: August 11, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: positron emission tomography; myocardial perfusion imaging; biodistribution; myocardial blood flow; pharmacological stress
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: 202107042; IND 157468 (Other Identifier: U.S. Food and Drug Administration); R01HL142297 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No