A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)
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|ClinicalTrials.gov Identifier: NCT01778218|
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : July 12, 2013
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease||Radiation: Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||2 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Center Pilot Study to Establish the 99mTc-EC-DG Imaging Protocol to Evaluate the Presence and Severity of Coronary Artery Disease|
|Study Start Date :||January 2013|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||March 2013|
99mTc-EC-DG injection followed by SPECT imaging during a cardiac rest study (Visit 1) and an exercise/regadenoson study (Visit 2)
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.
- Safety: The number of participants with Adverse Events [ Time Frame: From screening through 7 days after Investigational Product administration ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01778218
|United States, Kansas|
|Cardiovascular Imaging Technologies|
|Kansas City, Kansas, United States, 64111|
|Principal Investigator:||Timothy Bateman, MD||Cardiovascular Imaging Technologies|