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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging agent, 99mTc-ECDG, for diagnosing coronary artery disease, which affects the heart's blood vessels. The researchers aim to determine if this new agent outperforms the current method using a similar type of test. The process involves taking images of the heart at rest and under stress, then comparing these with results from a coronary angiogram, a special X-ray of the heart's arteries. Individuals who have undergone or are about to undergo specific heart tests and have not had recent heart interventions might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people, offering participants a chance to contribute to advancements in heart disease diagnosis.

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.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that the investigational imaging agent 99mTc-EC-DG is generally safe for humans. Previous studies examined its safety and found no major concerns. This agent allows doctors to see inside the body without surgery.

Additionally, 99mTc-Sestamibi, which is being compared in this study, has been safely used in many heart imaging studies. It is well tolerated, even by older adults, with no major safety issues reported.

Although 99mTc-EC-DG remains under study, its presence in a mid-stage trial suggests some confidence in its safety so far. This stage of research typically involves more participants to further assess side effects. The results are promising for those considering joining this trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about 99mTc-EC-DG for coronary artery disease because it offers a novel diagnostic approach. Unlike traditional imaging agents like 99mTc-Sestamibi, which mainly show blood flow, 99mTc-EC-DG targets glucose metabolism, providing a potentially clearer picture of coronary artery disease activity. This new mechanism could lead to more accurate diagnoses, helping doctors tailor treatments more effectively for patients. Additionally, its delivery via intravenous bolus injection ensures quick and efficient distribution in the body, which could streamline the diagnostic process.

What evidence suggests that 99mTc-EC-DG is effective for coronary artery disease?

Research has shown that 99mTc-EC-DG, which participants in this trial will receive, is a promising new tool for heart imaging. It highlights areas of the heart that might not be receiving enough blood, similar to current tests like 99mTc-Sestamibi. Early results suggest that 99mTc-EC-DG exits the bloodstream quickly, potentially leading to clear heart images. Studies have found it to be safe and well-tolerated by patients. This advancement could help doctors better understand heart health and predict potential heart problems. ^{1 3 6 7 8}

Who Is on the Research Team?

Gary Heller, MD

Principal Investigator

Consultant

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT01899833

NCT01899833 | Efficacy and Saftey Study of 99mTc-ECDG ... This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01778218

A Single Center Study to Establish the Imaging Protocol of ... This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine- ...

3. withpower.com withpower.com/trial/phase-3-myocardial-ischemia-2021-d1d2b

99mTc-ECDG for 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 ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT01778218?term=AREA%5BInterventionSearch%5D(%22Deoxyglucose%22)&rank=8

A Single Center Study to Establish the Imaging Protocol of ... This study will enroll up to 6 patients with a reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study. These ...

5. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/sites/books/n/micad/EC-DG-99mTc/

99mTc-Ethylenedicysteine-deoxyglucose - NCBI - NIH The effective dose equivalent was 0.0059 mSv/MBq (21.8 mrem/mCi). The blood clearance of 99mTc-EC-DG was rapid with <0.0005% ID at 1 h after ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01899833?term=99mTc%20Sestamibi&viewType=Table&rank=2

NCT01899833 | Efficacy and Saftey Study of 99mTc-ECDG ... A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

7. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/590664

Efficacy and Saftey Study of 99mTc-ECDG in ... This study will compare how well a new radiolabeled imaging agent ECDG compares to the current testing for coronary artery disease (radiolabeled Sestamibi) ...

8. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK23344/

99mTc-Ethylenedicysteine-deoxyglucose - NCBI - NIH 99m Tc-EC-DG by conjugation of two D-glucosamine (2-amino-deoxyglucose) molecules to ethylenedicysteine for single-photon emission computed tomography (SPECT) ...