Clinical trial NCT05280782: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging-Dosimetry Group
Official title: Development and Translation of Generator-Produced PET Tracer for Myocardial Perfusion Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Coronary Artery Disease
Keywords: myocardial perfusion imaging
pharmacological stress
biodistribution
positron emission tomography
myocardial blood flow
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-03-15
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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 \< 18 kg/m2 or \> 40 kg/m2.

Primary outcomes:
measure: Organ Dosimetry
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Biodistribution
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Total Effective Dose of the Radiotracer
timeFrame: 6 hours from 68Ga-Galmydar injection
Secondary outcomes:
measure: Clinically Significant Change in Blood Pressure.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Heart Rate.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Respiratory Rate.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Elevation in Oral Temperature
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in EKG Showing New AV Block
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in EKG Showing New Bradycardia
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Serum Chemistries: Sodium, Potassium, Chloride, CO2
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Serum Chemistries: Glucose, Calcium Creatinine, BUN, Total Bilirubin
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Serum Chemistries: Total Protein, Albumin.
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Serum Chemistries: Alkaline Phosphatase, ALT, AST
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in White Blood Cell Count (WBC)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Hemoglobin (Hgb)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Hematocrit (Hct)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Platelets
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Red Blood Cell Count (RBC)
timeFrame: 6 hours from 68Ga-Galmydar injection
measure: Clinically Significant Change in Mean Corpuscular Volume (MCV)
timeFrame: 6 hours from 68Ga-Galmydar injection
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Pamela K Woodard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.