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

NCT05280782 | Completed Early Phase 1 Results DMC FDA Drug

• 3 other identifiers: 202107042IND 157468R01HL142297
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Keywords

myocardial perfusion imaging; pharmacological stress; biodistribution; positron emission tomography; myocardial blood flow

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Clinically Significant Change in Blood Pressure.

  6 hours from 68Ga-Galmydar injection

• Clinically Significant Change in Heart Rate.

  6 hours from 68Ga-Galmydar injection

• Clinically Significant Change in Respiratory Rate.

  6 hours from 68Ga-Galmydar injection

• Clinically Significant Elevation in Oral Temperature

  6 hours from 68Ga-Galmydar injection

• Clinically Significant Change in EKG Showing New AV Block

  6 hours from 68Ga-Galmydar injection

Study Arms (1)

Dosimetry Group

EXPERIMENTAL

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

Interventions

Ga-68 Galmydar DRUG

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

Also known as: IND 157468

Dosimetry Group

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy men and women, 18-99 years of age and any race

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related 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.

  PMID: 29454148 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Dr. Pamela K. Woodard
• Organization: Washington University School of Medicine

woodardp@wustl.edu

314-362-7100

Study Officials

• Pamela K Woodard, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: H M Wilson Professor of Radiology

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: March 15, 2022
• Study Start: January 5, 2022
• Primary Completion: May 1, 2022
• Study Completion: May 1, 2022
• Last Updated: September 8, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)