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

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

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.

Study Overview

• Status: Terminated
• Conditions: Myocardial Infarction; Ischemic Heart Disease
• Intervention / Treatment: Drug: Half-dose of the Tc99-m 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 atrioventricular block or sinus node disease (unless patients have a functioning artificial pacemaker), known hypersensitivity to aminophylline or adenosine
• Inability to give informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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 Names: technetium (Tc-99m) sestamibi, Cardiolite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sum Rest Score	Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The scores over 17 segments were summed to report the Sum Rest Score (SRS), ie. the greater the SRS, the larger the perfusion defect.	Baseline
Segments With Resting Perfusion Defect	Left ventricular myocardium was divided into standardized 17-segments with 6 equiangular segments in the basal region, 6 equiangular segments in the mid region, 4 equiangular segments in the apical regions, and 1 region in the apex (Cerqueira MD, et al., J Nucl Cardiol 2002;9:240-5). Each segment was scored on a scale from 0 to 4 to indicate the severity of the perfusion defect (0=no perfusion defect; 1=mild perfusion defect; 2=moderate perfusion defect; 3=severe perfusion defect; and 4=absent perfusion). The number of segments with a score of 1 or greater were summed to obtain the number of segments with a resting perfusion defect.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Image Quality Score	Each reconstructed image was subjectively scored by the expert readers to determine the overall image quality. The Image Quality Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).	Baseline
Diagnostic Confidence Score	Each reconstructed image was subjectively scored by the expert readers to determine the expert reader's diagnostic confidence in scoring and interpreting the perfusion scores. The Diagnostic Confidence Score of the reconstructed images were graded on a 4-point scale. (1=Poor; 2=Fair; 3=Good; and 4=Excellent).	Baseline

Collaborators and Investigators

• Sponsor: Edwin Wu
• Collaborators: Astellas Pharma Global Development, Inc.
• Investigators: Principal Investigator: Edwin Wu, M.D., FACC, Northwestern University

Study record dates

Study Major Dates

• Study Start: October 1, 2011
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: December 19, 2011
• First Submitted That Met QC Criteria: December 22, 2011
• First Posted (Estimate): December 26, 2011

Study Record Updates

• Last Update Posted (Estimate): February 24, 2016
• Last Update Submitted That Met QC Criteria: January 27, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: SPECT MPI; Tomography, Emission-Computed, Single-Photon; Wide Beam Reconstruction
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Infarction; Infarction; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sestamibi
• Other Study ID Numbers: STU53243