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

NCT01778218 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2013-07-12

No results posted yet for this study

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).

Conditions

Interventions

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.

Sponsors & Collaborators

  • Cell>Point LLC

    lead INDUSTRY

Principal Investigators

  • Timothy Bateman, MD · Cardiovascular Imaging Technologies

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-02-28
Completion
2013-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01778218 on ClinicalTrials.gov