A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)

Recruiting in Palo Alto (17 mi)

Overseen by Timothy Bateman, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Cell>Point LLC

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This study will assess the safety and tolerability of the investigational radiolabeled imaging agent technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). Additionally, the study will determine the specific times to best image the heart using a SPECT camera with the investigational imaging agent and compare the images to those taken while undergoing the standard rest and exercise/regadenoson testing previously performed to detect the presence and severity of Coronary Artery Disease (CAD).

Research Team

Timothy Bateman, MD

Principal Investigator

Cardiovascular Imaging Technologies

Eligibility Criteria

Inclusion Criteria

Age > 18 years

Reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study completed within 30 days prior to screening;

When possible, a coronary angiography will be clinically planned; patient and treating physician must be agreeable to completing the angiogram after the 99mTc-EC-DG exercise/regadenoson study in order for the procedure to be performed.

Treatment Details

Interventions

• 99mTc-EC-DG (Radiopharmaceutical)

Participant Groups

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

99mTc-EC-DG injection followed by SPECT imaging during a cardiac rest study (Visit 1) and an exercise/regadenoson study (Visit 2)

Who Is Running the Clinical Trial?

Cell>Point LLC

Lead Sponsor

Trials

5

Recruited

240+