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

This study is ongoing, but not recruiting participants.
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 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Myocardial Infarction
Ischemic Heart Disease
Drug: Half-dose of the Tc99-m sestamibi (Cardiolite)

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Feasibility of Half-Dose Radiopharmaceutical Administration Utilizing Wide-Beam Reconstruction

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 160
Study Start Date: October 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01499654

Locations
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Edwin Wu
Astellas Pharma Global Development, Inc.
Investigators
Principal Investigator: Edwin Wu, M.D., FACC Northwestern University
  More Information

No publications provided

Responsible Party: Edwin Wu, Associate Professor of Medicine and Radiology, Northwestern University
ClinicalTrials.gov Identifier: NCT01499654     History of Changes
Other Study ID Numbers: STU53243
Study First Received: December 19, 2011
Last Updated: March 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
SPECT MPI
Tomography, Emission-Computed, Single-Photon
Wide Beam Reconstruction

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Infarction
Myocardial Infarction
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 15, 2014