Myocardial Perfusion Imaging Galmydar Rest/Stress

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

Sponsors

Lead Sponsor: Washington University School of Medicine

Collaborator: National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)

Source Washington University School of Medicine
Brief Summary

A single center, phase 0/1 clinical imaging study designed to assess the role of [68Ga]Galmydar PET/CT imaging in human subjects.

Detailed Description

The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar PET/CT MPI for the noninvasive detection of coronary artery disease. The study will evaluate [68Ga]Galmydar PET/CT MPI in comparison to [13N]ammonia PET/CT MPI to semi-quantitatively assess regional myocardial perfusion and quantitatively assess myocardial blood flow (MBF) in patients with suspected or known coronary artery disease (CAD) undergoing clinical SPECT MPI. In addition, perfusion and MBF findings with [68Ga]Galmydar will be compared to the results of coronary morphology or stenosis severity in those patients undergoing invasive coronary angiography (ICA) based on abnormal SPECT MPI. The performance of rest/stress [68Ga]Galmydar PET/CT in comparison to [13N]ammonia PET/CT in normal subjects without cardiovascular disease will be performed as a control. The primary objective of the proposed study is to evaluate the potential of [68Ga]Galmydar PET/CT MPI for the noninvasive detection of coronary artery disease. The study will evaluate [68Ga]Galmydar PET/CT MPI in comparison to [13N]ammonia PET/CT MPI in the same subjects to semi quantitatively assess regional myocardial perfusion and quantitatively assess myocardial blood flow (MBF) in patients with suspected or known coronary artery disease (CAD) undergoing clinical SPECT MPI. In addition, perfusion and MBF findings with [68Ga]Galmydar will be compared to the results of coronary morphology or stenosis severity in those patients undergoing invasive coronary angiography (ICA) based on abnormal SPECT MPI. The performance of rest/stress [68Ga]Galmydar PET/CT in comparison to [13N]ammonia PET/CT in normal subjects without cardiovascular disease will be performed as a control. Vital signs, serum chemistries, and serum blood counts will also be obtained.

Overall Status Recruiting
Start Date 2022-11-11
Completion Date 2024-04-01
Primary Completion Date 2024-04-01
Phase Early Phase 1
Study Type Interventional
Primary Outcome
Measure Time Frame
Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake Comparison to regional uptake on 13N-ammonia PET/CT performed 3-30 days after the 68Ga-Galmydar PET/CT
Secondary Outcome
Measure Time Frame
Assessment of myocardial blood flow on 68Ga-Galmydar PET/CT Comparison to regional MBF on 13N-ammonia PET/CT performed 3-30 days after the 68Ga-Galmydar PET/CT
Change in systolic or diastolic blood pressure. 6 hours from 68Ga-Galmydar injection
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
Number of patients with new AV Block 6 hours from 68Ga-Galmydar injection
Number of patients with new bradycardia 6 hours from 68Ga-Galmydar injection
Clinically significant change in serum chemistries: sodium, potassium, chloride, CO2 6 hours from 68Ga-Galmydar injection
Clinically significant change in serum chemistries: glucose, calcium creatinine, BUN, total bilirubin 6 hours from 68Ga-Galmydar injection
Clinically significant change in serum chemistries: total protein, albumin. 6 hours from 68Ga-Galmydar injection
Clinically significant change in serum chemistries: alkaline phosphatase, ALT, AST 6 hours from 68Ga-Galmydar injection
Clinically significant change in white blood cell count (WBC) 6 hours from 68Ga-Galmydar injection
Clinically significant change in hemoglobin (Hgb) 6 hours from 68Ga-Galmydar injection
Clinically significant change in hematocrit (Hct) 6 hours from 68Ga-Galmydar injection
Clinically significant change in platelets 6 hours from 68Ga-Galmydar injection
Clinically significant change in red blood cell count (RBC) 6 hours from 68Ga-Galmydar injection
Clinically significant change in mean corpuscular volume (MCV) 6 hours from 68Ga-Galmydar injection
Enrollment 30
Condition
Intervention

Intervention Type: Drug

Intervention Name: Ga-68 Galmydar

Description: Two intravenous injection of the PET radiotracer 68Ga-Galmydar.

Arm Group Label: Rest/ Stress imaging day 1

Other Name: IND 157468

Intervention Type: Drug

Intervention Name: 13N-ammonia

Description: Two intravenous Injection of PET radiotracer 13N-Ammonia.

Arm Group Label: rest/ stress imaging day 2

Eligibility

Criteria:

Inclusion Criteria: - Male and female, 18-99 years of age and any race; - Have had a prior clinical SPECT MPI positive for ischemia in two myocardial segments and referred for invasive coronary angiography (ICA) or have had a prior clinical SPECT MPI negative for ischemia; Exclusion Criteria: - Inability to receive and sign informed consent; - Percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 6-months prior to SPECT or in the intervening days between SPECT and PET examination; - Participants who have received chemotherapeutic agents within 6 months of enrollment; - Heart failure (left ventricular ejection fraction ≤ 35%); - Known non-ischemic cardiomyopathy; - Inability to undergo pharmacologic stress testing with regadenoson (Lexiscan). Contraindications include: - Symptomatic bradycardia or second to third degree atrioventricular (AV) block; - Pre-existing obstructive lung disease with active wheezing, i.e., COPD, asthma with active wheezing that precludes the safe administration of the pharmacological stress agent according to the approved label; - Uncontrolled and severe hypertension (e.g. systolic blood pressure >200 mmHg, diastolic blood pressure >110 mmHg); - Baseline hypotension (e.g. systolic blood pressure < 90 mmHg, diastolic blood pressure <50 mmHg); - Women who are pregnant or breastfeeding; - Severe claustrophobia; - Weight ≥ 500 lbs (weight limit of PET/CT table)

Gender:

All

Minimum Age:

18 Years

Maximum Age:

99 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Pamela K Woodard, M.D Principal Investigator Washington University School of Medicine
Overall Contact

Last Name: Dakkota M Thies

Phone: 314-747-3839

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Washington University School of Medicine Dakkota m Thies 314-747-3839 [email protected] Pamela K Woodard, M.D Principal Investigator Thomas Schindler, MD, PHD Sub-Investigator Vijay Sharma, PHD Sub-Investigator
Location Countries

United States

Verification Date

2022-11-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Washington University School of Medicine

Investigator Full Name: Pamela Woodard, MD

Investigator Title: H M Wilson Professor of Radiology

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Rest/ Stress imaging day 1

Type: Experimental

Description: Participants will receive two [68Ga]Galmydar intravenous administrations, 4 mCi during rest and 8 mCi during stress for the PET MPI performed on Imaging Day-1.

Label: rest/ stress imaging day 2

Type: Experimental

Description: On Imaging Day-2, participants will receive two single administrations each of 10 mCi of 13N-Ammonia during the rest and stress PET MPI.

Patient Data No
Study Design Info

Allocation: Non-Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: Patients with known or suspected disease and normal controls (no known disease) will both undergo [68Ga]Galmydar PET/CT MPI and [13N]ammonia PET/CT MPI

Primary Purpose: Diagnostic

Masking: None (Open Label)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact [email protected]. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Coronary Artery Disease

Clinical Trials on Ga-68 Galmydar