Half-Dose Radiopharmaceutical in Wide Beam Reconstruction (REGA-1102)

This study is currently recruiting participants.

Verified March 2013 by Northwestern University

Sponsor:

Collaborator:

Astellas Pharma Global Development, Inc.

Information provided by (Responsible Party):

Edwin Wu, Northwestern University

ClinicalTrials.gov Identifier:

NCT01499654

First received: December 19, 2011

Last updated: March 28, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

December 19, 2011

Last Updated Date

March 28, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

image quality [ Time Frame: Subject participation is complete following imaging portion of stress test. Data will be collected and images compared within 24 hours of testing. All images will be analyzed and compared at the completion of the study, est. Feb, 2013 ] [ Designated as safety issue: No ]

SPECT images will be randomized and de-identified. Each subject will have 3 images in combinations of radiopharmaceutical dose and reconstruction algorithm for analysis. Perfusion data will be reported using a 17-segment model and scored on a scale between 0 and 4. Scores will be obtained semi-quantitatively by 2 expert readers. The sum of the scores over 17 segments will be summed to report the summed rest score (SRS). Additionally, images will be classified as diagnostic vs. non-diagnostic and the quality of the images will be graded on a scale from 0 to 3.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01499654 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Half-Dose Radiopharmaceutical in Wide Beam Reconstruction

Official Title ^ICMJE

Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction

Brief Summary

This study is recruiting patients already scheduled for a single photon emission computed tomography myocardial perfusion imaging (SPECT-MPI) test. SPECT-MPI is a nuclear imaging technique that uses a radioactive substance, or radiotracer, and special equipment to create three-dimensional (3D) images of the heart. Radiotracer is a radioactive dye that will make the structures of the heart visible and is routinely used to view blood flow in the heart, scan for damaged heart tissue, or assess heart function.

For a routine SPECT-MPI test, the radiotracer is given in one dose at the beginning of the test, followed by taking resting images of the heart. For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Participants will receive the same amount of radioactive material that would normally be given for this test; however, it will be administered in two half-doses. Participation in this study will add about 30 minutes to the time it takes to complete the routine test. The investigators expect to enroll about 160 subjects in this study at Northwestern.

Detailed Description

Subjects in this study will proceed to the nuclear cardiology laboratory for their scheduled nuclear stress test. After informed consent is obtained, the study doctor or research staff member will ask detailed questions about the subject's current health, medications and medical history, and the subject's medical chart will be reviewed including results of any previous nuclear images.

For the test, a small catheter (tube) will be placed in a vein in the subject's arm to administer the radioactive imaging agent, Tc-99m sestamibi. Subjects will be given half (1/2) of the normal Tc-99m sestamibi dose and then the study staff will obtain resting images pictures of the heart. After this set of images, the subject will be given the remaining half of the radioactive imaging agent followed by a second set of images.

After this, the subject will then undergo the stress portion of the test in the usual manner as prescribed by the referring physician.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Myocardial Infarction
Ischemic Heart Disease

Intervention ^ICMJE

Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

Researchers will administer half of the radiotracer (Cardiolite), obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses.

Other Name: technetium (Tc-99m) sestamibi, Cardiolite

Study Arm (s)

Experimental: Half-dose radiotracer administration

For this study, researchers would like to administer half of the radiotracer, obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses.

Intervention: Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

160

Estimated Completion Date

January 2014

Estimated Primary Completion Date

January 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients over the age of 18 years
Undergoing nuclear stress testing
History of myocardial infarction, cardiomyopathy, heart failure or prior nuclear studies with resting perfusion defects

Exclusion Criteria:

Unwilling or unable to undergo an additional resting SPECT acquisition
Clinical contraindications to nuclear stress testing including acute myocardial infarction
- For patients undergoing exercise treadmill stress testing:
Left bundle branch block or artificial ventricular pacemaker
- For patients undergoing regadenoson (Lexiscan) stress testing:
Moderate to severe chronic obstructive pulmonary disease or asthma, second- or third degree
AV block or sinus node disease (unless patients have a functioning artificial pacemaker), known hypersensitivity to aminophylline or adenosine
Inability to give informed consent

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Clinical Trials Unit

312-926-4000

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01499654

Other Study ID Numbers ^ICMJE

STU53243

Has Data Monitoring Committee

Responsible Party

Edwin Wu, Northwestern University

Study Sponsor ^ICMJE

Edwin Wu

Collaborators ^ICMJE

Astellas Pharma Global Development, Inc.

Investigators ^ICMJE

Principal Investigator:

Edwin Wu, M.D., FACC

Northwestern University

Information Provided By

Northwestern University

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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