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Radioactive Agent

Myocardial Perfusion Imaging for Coronary Artery Disease

Phase < 1

Recruiting

Led By Pamela K Woodard, M.D

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

Be older than 18 years old

Must not have

Known non-ischemic cardiomyopathy

Inability to receive and sign informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 120 minutes post-injection of 68ga-galmydar

Awards & highlights

No Placebo-Only Group

Summary

This trial will study how a type of medical imaging can help diagnose diseases in humans.

Who is the study for?

This trial is for men and women aged 18-99 with a history of heart issues, specifically those who've had certain types of heart scans showing possible blockages and are referred for further testing. It's not suitable for pregnant or breastfeeding women, individuals over 500 lbs, those with severe claustrophobia, uncontrolled high blood pressure, recent major heart procedures, chemotherapy within the last six months, serious lung diseases with wheezing, severe heart failure or conditions that prevent stress testing.

What is being tested?

The study is evaluating [68Ga]Galmydar PET/CT imaging to see how well it can identify areas of the heart muscle that aren't getting enough blood flow in patients suspected to have coronary artery disease. This phase 0/1 trial will compare Galmydar images against traditional SPECT MPI results.

What are the potential side effects?

Potential side effects may include reactions related to the PET/CT scan such as discomfort from lying still during the procedure. The tracers used (13N-ammonia and Ga-68 Galmydar) could cause allergic reactions or other side effects which will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I've had a heart scan showing reduced blood flow or a normal heart scan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a type of heart disease not caused by blocked arteries.

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I am unable to understand or sign the consent form.

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My blood pressure is not higher than 200/110 mmHg.

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I cannot have a stress test with Lexiscan.

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I have severe claustrophobia.

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I have a slow heartbeat or a block in my heart's electrical signals.

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I am not pregnant or breastfeeding.

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My heart's pumping ability is significantly reduced.

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I weigh less than 500 lbs.

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I have lung problems like COPD or asthma that cause wheezing and make certain treatments unsafe for me.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 120 minutes post-injection of 68ga-galmydar

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 120 minutes post-injection of 68ga-galmydar

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 120 minutes post-injection of 68ga-galmydar for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Semiquantitative assessment of 68Ga-Galmydar PET/CT uptake

Secondary study objectives

Assessment of myocardial blood flow on 68Ga-Galmydar PET/CT

Change in heart rate.

Change in systolic or diastolic blood pressure.

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Symptomatic Patients with Normal SPECTExperimental Treatment1 Intervention

Patients in this group have had a SPECT MPI examination that is normal and do not have an invasive coronary angiography (ICA) referral. Participants will receive one \[68Ga\]Galmydar intravenous administration, 2 mCi during rest for the \[68Ga\]Galmydar PET MPI.

Group II: Symptomatic Patients with Abnormal SPECTExperimental Treatment1 Intervention

Patients in this group have had a SPECT MPI examination that is positive for ischemia in two myocardial segments and have been referred for invasive coronary angiography (ICA) as part of their routine standard-of-care. Subjects will undergo \[68Ga\]Galmydar PET/CT prior to any intervention. Participants will receive one \[68Ga\]Galmydar intravenous administration, 2 mCi during rest.

Group III: Asymptomatic Subjects (Normal Controls)Experimental Treatment2 Interventions

Normal control subjects are asymptomatic, without history of cardiovascular disease or significant cardiovascular risk factors. These participants will receive two \[68Ga\]Galmydar intravenous administrations, 2 mCi during rest and 4 mCi during stress for the \[68Ga\]Galmydar PET MPI performed on Imaging Day-1. On Imaging Day-2, asymptomatic subjects will receive two single intravenous administrations each of 10 mCi of \[13N\]Ammonia during the rest and stress PET MPI. \[68Ga\]Galmydar and \[13N\]Ammonia imaging visits will be separated by a minimum of 3 days.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ga-68 Galmydar

2022

Completed Early Phase 1

~10

0 / 11Eligibility criteria met