99mTc-ECDG for Coronary Artery Disease

Overseen By Cynthia Phurrough, BS

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cell>Point LLC

Must not be taking: Anti-anginals, Investigational drugs

Disqualifiers: Cardiomyopathy, CHF, Malignant disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

60 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) during a rest and stress cardiac test as documented from results of a coronary angiogram (if performed).

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications, but it does require no change in medical therapy between study procedures. This means you should continue your current medications without starting new ones or changing doses.

What data supports the effectiveness of the drug 99mTc-Sestamibi for treating coronary artery disease?

Research shows that 99mTc-Sestamibi is effective in predicting adverse cardiac outcomes and assessing heart muscle health in patients with coronary artery disease. It helps doctors evaluate heart function and guide treatment decisions, especially in patients with chest pain or heart dysfunction. ^{1 2 3 4 5}

Is 99mTc-Sestamibi safe for use in humans?

99mTc-Sestamibi has been used safely in various studies for heart-related imaging, including in older patients, without significant safety concerns reported. ^{6 7 8 9 10}

How does the drug 99mTc-Sestamibi differ from other treatments for coronary artery disease?

99mTc-Sestamibi is unique because it is a radioactive tracer used in imaging to assess blood flow in the heart, helping to detect coronary artery disease by highlighting areas with reduced blood supply. Unlike other treatments that directly address the disease, this drug is used for diagnostic purposes to guide further treatment decisions. ^{6 11 12 13 14}

Research Team

Gary Heller, MD

Principal Investigator

Consultant

Eligibility Criteria

This trial is for adults over 18 with coronary artery disease who've had a standard SPECT perfusion rest/stress study within the last 30 days. Participants must be planning or have completed a coronary angiography without intervention and agree to not change their medical therapy during the study.

Inclusion Criteria

The patient is able to provide informed consent to participate in this study

No change in medical therapy between study procedures

I am older than 18 years.

Exclusion Criteria

Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing

I have had bypass surgery in the past.

Pregnant or nursing

Timeline

Screening

Participants are screened for eligibility to participate in the trial

3 to 30 days

Imaging Procedures

Participants undergo a sequence of imaging procedures including 99mTc-EC-DG rest study, 99mTc-SPECT MPI rest/stress study, and 99mTc-EC-DG stress study

3 to 9 days

Multiple visits for imaging procedures

Follow-up

Participants are monitored for safety and effectiveness after imaging procedures

14 days

Treatment Details

Interventions

• 99mTc-Sestamibi

Trial Overview The trial is testing a new imaging agent called ECDG against the current standard, Sestamibi, in detecting coronary artery disease during cardiac tests. The effectiveness will be measured alongside results from coronary angiograms.

Participant Groups

Group I: 99mTc-EC-DG, Diagnostic Experimental Treatment 1 Intervention

99mTc-EC-DG (25 ± 5 mCi, up to 250 µg EC-DG) will be administered by intravenous (IV) bolus injection. Other Name:Technetium-99m-labeled Ethylenedicysteine-Deoxyglucose

Who Is Running the Clinical Trial?

Cell>Point LLC

Lead Sponsor

Trials

5

Recruited

240+

References

1. England pubmed.ncbi.nlm.nih.gov

Prediction of mortality in patients with coronary artery disease undergoing vasodilator stress testing: a comparison between 99mTc-tetrofosmin and 99mTc-sestamibi. [2016]

2. India pubmed.ncbi.nlm.nih.gov

Myocardial Perfusion Scan Study before and after On-Pump Coronary Artery Bypass Grafting Surgery - A Single-Center Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Value of acute rest sestamibi perfusion imaging for evaluation of patients admitted to the emergency department with chest pain. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Prognostic implications of Tc-99m sestamibi viability imaging and subsequent therapeutic strategy in patients with chronic coronary artery disease and left ventricular dysfunction. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Multicenter trial validation for quantitative analysis of same-day rest-stress technetium-99m-sestamibi myocardial tomograms. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Infarct size after acute myocardial infarction measured by quantitative tomographic 99mTc sestamibi imaging predicts subsequent mortality. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Potential and limitations of Tc-99m sestamibi scintigraphy for the diagnosis of myocardial viability. [2016]

8. United States pubmed.ncbi.nlm.nih.gov

Resting sestamibi imaging for the prognosis of low-risk chest pain. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Diagnostic efficacy of stress technetium 99m-labeled sestamibi myocardial perfusion single-photon emission computed tomography in detection of coronary artery disease among patients over age 80. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Predicting adverse outcome with exercise SPECT technetium-99m sestamibi imaging in patients with suspected or known coronary artery disease. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

[Comparison between myocardial perfusion scintigraphy with thallium-201 and technetium-99m-Sestamibi (methoxy isobutyl isonitrile) for the detection of coronary atherosclerotic disease]. [2016]

12. Australia pubmed.ncbi.nlm.nih.gov

Myocardial perfusion imaging with technetium-99m sestamibi SPECT in the evaluation of coronary artery disease. [2019]

13. United States pubmed.ncbi.nlm.nih.gov

Myocardial uptake of thallium 201 and technetium 99m-labeled sestamibi after ischemia and reperfusion: comparison by quantitative dual-tracer autoradiography in rabbits. [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Spontaneous silent myocardial ischemia assessed by technetium-99m-sestamibi imaging. [2016]