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

Primary Purpose

Coronary Artery Disease

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

99mTc-Sestamibi

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, CAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age > 18 years
Either of the following:
1. 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
2. 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.

Exclusion Criteria:

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

Sites / Locations

Tom Hennebry, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

99mTc-EC-DG, Diagnostic

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety: The number of participants with Adverse Events

Reported or observed Adverse Events

Full Information

NCT ID

NCT01899833

First Posted

July 10, 2013

Last Updated

January 28, 2021

Sponsor

Cell>Point LLC

1. Study Identification

Unique Protocol Identification Number

NCT01899833

Brief Title

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

Official Title

A Prospective, Open-label, Multicenter Study With Blinded Over-reading Characterizing the Efficacy and Safety of 99mTc-EC-DG in the Evaluation of Coronary Artery Disease (CAD)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Unknown status

Study Start Date

January 10, 2021 (Actual)

Primary Completion Date

December 2022 (Anticipated)

Study Completion Date

January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Cell>Point LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

Detailed Description

This study will be a prospective, open-label, multi-center study assessing the efficacy and safety of 99mTc-EC-DG compared to 99mTc-SPECT MPI imaging for detecting the presence, location, and severity of CAD as established by coronary angiography. Approximately 60 patients will be enrolled in the study. Group 1 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and their physician has planned for coronary angiography but angiography has not yet been performed. In addition, the patient has not had coronary artery bypass graft (CABG). These patients can be enrolled. Group 2 will be patients who have been evaluated for CAD within 3 to 30 days by any cardiovascular diagnostic imaging method (nuclear, ultrasound, CTA, MRI, etc.) and the patient has already had coronary angiography performed but has not received any coronary intervention subsequent to the procedure. The following sequence of imaging procedures will be performed for both Group 1 and 2 patients: The first procedure will be a 99mTc-EC-DG rest study. This will be followed within 24 hours to 3 days with a 1-day protocol 99mTc-SPECT MPI rest/stress study. This will be followed within 24 hours to 3 days with a 99mTc-EC-DG stress study. For both Group 1 and 2, if 1 of the diagnostic imaging procedures performed to evaluate the presence of CAD was a traditional 99mTc-SPECT MPI rest/stress study, this procedure must be repeated as 1 of the 3 SPECT imaging procedures required by the trial protocol. The modality for provocative stress testing (exercise, pharmacologic, or exercise/pharmacologic) will be matched between the 99mTc-SPECT study and the 99mTc-EC-DG study. All prospectively performed 99mTc-EC-DG and 99mTc-SPECT studies will be conducted using regadenoson as the pharmacologic stress agent. All imaging studies (99mTc-EC-DG, 99mTc-SPECT, coronary angiography) will be over-read by blinded, trained reviewers. The consensus blinded read will determine and record the location of the CAD by relating the wall of the myocardium affected to include: anterior, Inferior, lateral, septal and apex. The angiography study will identify the arteries associated with the CAD; namely, left anterior descending, circumflex or right coronary arteries. The study will also determine the severity of the CAD by visually comparing the size and intensity of the ischemic signal on rest and stress images obtained approximately 15 and 60 minutes post injection. The results from the consensus blinded read of coronary angiography will be considered truth for the presence, location, and severity of obstructive CAD and degree of stenosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary Artery Disease, CAD

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Patients receive typical imaging agent for rest and stress imaging then receive investigational imaging agent for rest and stress imaging

Masking

None (Open Label)

Allocation

N/A

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

99mTc-EC-DG, Diagnostic

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

99mTc-Sestamibi

Other Intervention Name(s)

99mTc-Sestamibi (Mibi)

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Visit 1a through Visit 3 approximately 3 to 20 days

Secondary Outcome Measure Information:

Title

Safety: The number of participants with Adverse Events

Description

Reported or observed Adverse Events

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Gary Heller, MD

Organizational Affiliation

Consultant

Official's Role

Principal Investigator

Facility Information:

Facility Name

Tom Hennebry, MD

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73210

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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