NCT01778218

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

A Single Center Pilot Study to Establish the 99mTc-EC-DG Imaging Protocol to Evaluate the Presence and Severity of Coronary Artery Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Cell>Point LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

The study will assess the safety and tolerability of technetium-99m-labeled ethylenedicysteine-deoxyglucose (99mTc-EC-DG). An outcome will be to develop an imaging protocol for a multicenter trial that will measure the specific imaging parameters required for determination of sensitivity and specificity of 99mTc-EC-DG in a cardiovascular single photon emission computed tomography (SPECT) study compared to an exercise/regadenoson 99mTc- Sestamibi (MIBI) study for detection of the presence and, when available, severity of coronary artery disease (CAD) as documented by coronary angiography when available. This study will be a single-center, prospective, open-label study of up to 6 patients with positive findings from a MIBI (99mTc-sestamibi) exercise/regadenoson study within 30 days for evaluation of CAD. Patients who meet study eligibility criteria will undergo a 99mTc-EC-DG rest study and a 99mTc-EC-DG exercise/regadenoson study. When possible, patients enrolled will have clinical plans for a coronary angiography study to confirm presence and severity of CAD. This study will enroll up to 6 patients with a reversible perfusion defect indicative of CAD on a MIBI exercise/regadenoson study. These patients will undergo a 99mTc-EC-DG rest study and an exercise/regadenoson study.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
RADIATION	Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose	An injection of Technetium ethylenedicysteine-deoxyglucose (99mTc-EC-DG) to yield a target activity of 25 mCi (range of 10-25 mCi) with no more than 250 micrograms of EC-DG to be administered (there must be a minimum of 24 hours between Visit 1 and 2 administrations). Investigational Product to be given by IV push.

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-02-01
• Completion: 2013-03-01
• First posted: 2013-01-29
• Last updated: 2013-07-12

Locations

1 site across 1 country: United States