Efficacy and Saftey Study of 99mTc-ECDG in the Evaluation of Coronary Artery Disease (CAD)

NCT01899833 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: CP-ECDG-C3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; CAD

Outcome Measures

Primary Outcomes (1)

• Efficacy: Characterization of the efficacy of 99mTCc-ECDG in the evaluation of Coronary Artery Disease

  1\. Determine efficacy (sensitivity and specificity) of 99mTc-ED-DG: i. Compare efficacy of a rest and stress study at approximately 15 minutes post injection compared with efficacy of a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.\* ii. Compare efficacy of a rest and stress study at approximately 60 minutes post injection compared with a standard 99mTc-SPECT rest/stress perfusion study for detecting the presence of CAD using invasive coronary angiography as the truth standard.\* \* Images will be displayed using the standard Cedars Sinai tomographic display software which projects images in the short axis, vertical long, and horizontal long axis displays.

  Visit 1a through Visit 3 approximately 3 to 20 days

Secondary Outcomes (1)

• Safety: The number of participants with Adverse Events

  From screeniing through up to 14 days after last study related procedure

Study Arms (1)

99mTc-EC-DG, Diagnostic

EXPERIMENTAL

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

Diagnostic Test: 99mTc-Sestamibi

Interventions

99mTc-Sestamibi DIAGNOSTIC_TEST

An injection of 99mTC-Sestamibi will be administered by IV push under medically observed conditions.

Also known as: 99mTc-Sestamibi (Mibi)

99mTc-EC-DG, Diagnostic

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years
• Either of the following:
• Standard 99mTc-SPECT perfusion rest/stress study completed within 30 days prior to screening and a coronary angiography study is clinically planned after the 99mTc-C-DG rest and stress visits in this study
• Coronary angiography study planned or completed within 30 days of screening and no coronary intervention has been performed and willingness to complete a standard 99mTc-SPECT rest/stress study
• The patient is able to provide informed consent to participate in this study
• No change in medical therapy between study procedures.

You may not qualify if:

• Known cardiomyopathy or history of congestive heart failure (CHF) due to left ventricular systolic dysfunction (ejection fraction \< 40%)
• Starting a new anti-anginal drug or performance of revascularization prior to completing the 99mTc-EC-DG rest and stress study visits
• Contraindication for provocative stress testing based on American College of Cardiology/American Heart Association (ACC/AHA) guidelines for exercise or pharmacologic testing
• Intolerance or inability to receive sestamibi, tetrofosmin, or regadenoson, or an inability or unwillingness to exercise on a graded treadmill or receive pharmacologic stress
• Inability to lie still for approximately 30 minutes during image acquisition
• Women of childbearing potential, unless willing to use adequate contraception throughout the duration of the trial. Adequate contraception is considered hormonal contraception for \> 3 months prior to entry, intrauterine device (IUD) in place for at least 3 months, double barrier methods (condoms, diaphragm or spermicide), abstinence, or a partner with non-reversed vasectomy \> 40 days prior to entry.
• Pregnant or nursing
• History of malignant disease (excluding treated basal cell or squamous cell carcinoma of skin, or low grade cancers that are stable and not interfering with exercise may be allowed with permission from the Medical Monitor) within 5 years prior to screening. Resolution of a prior malignancy more than 5 years prior to screening must be deemed as cured by the investigator
• Any physical, psychological or substance abuse (drug or alcohol) condition which, in the opinion of the investigator, would interfere with the ability to provide informed consent or comply with study instructions or may adversely affect the safety of the patient if enrolled in this trial
• A known allergy to 99mTc-EC-DG or its components
• Inability to adhere to requirements specific to the study site's protocols for imaging and exercise/pharmacological stress testing, including but not limited to dietary restrictions and prohibited medications
• Received an investigational drug within 30 days prior to this study
• Prior bypass surgery
• Enrolled or plans to enroll in another clinical trial during this study

Sponsors & Collaborators

• Cell>Point LLC: lead

Study Sites (1)

Tom Hennebry, MD

Oklahoma City, Oklahoma, 73210, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Gary Heller, MD

  Consultant

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cynthia Phurrough, BS

CONTACT

5136180337; cphurrough@camargopharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients receive typical imaging agent for rest and stress imaging then receive investigational imaging agent for rest and stress imaging

Study Record Dates

• First Submitted: July 10, 2013
• First Posted: July 16, 2013
• Study Start: May 10, 2025
• Primary Completion: December 1, 2025
• Study Completion: April 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)