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

Coronary Artery Disease Clinical Trial

— GALMYDAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05280782
• Other study ID #: 202107042
• Secondary ID: IND 157468R01HL1
• Status: Completed
• Phase: Early Phase 1
• Start date: January 5, 2022
• Est. completion date: May 1, 2022

Study information

• Verified date: August 2023
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Drug:
• Ga-68 Galmydar
Single intravenous injection of the PET radiotracer 68Ga-Galmydar.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Clinically Significant Change in Respiratory Rate.	A respiratory rate of < 12 or > 20 breaths/min.	6 hours from 68Ga-Galmydar injection
Secondary	Clinically Significant Elevation in Oral Temperature	Oral temperature of >100 degrees F.	6 hours from 68Ga-Galmydar injection
Secondary	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
Secondary	Clinically Significant Change in EKG Showing New Bradycardia	New heart rate < 40 BPM.	6 hours from 68Ga-Galmydar injection
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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