Ignite Creation Date:
2025-12-25 @ 4:48 AM
Ignite Modification Date:
2026-03-03 @ 4:49 PM
Study NCT ID:
NCT01778218
Status:
COMPLETED
Last Update Posted:
2013-07-12
First Post:
2013-01-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Single Center Study to Establish the Imaging Protocol of 99mTc-EC-DG in Evaluating the Presence and Severity of Coronary Artery Disease (CAD)
Sponsor:
Cell>Point LLC
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: