Clinical Trials Directory

Trials / Completed

CompletedNCT02280941

Cadmium-zinc-telluride (CZT) Imaging of Myocardial Blood Flow (MBF) (SPECT MBF)

Comparison of Myocardial Blood Flow Measurements With Dedicated Solid State SPECT Camera Imaging and 99mTc-Tetrofosmin Versus PET Imaging and Rubidium-82

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
66 (actual)
Sponsor
Ottawa Heart Institute Research Corporation · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

This study is being done to compare the blood flow measurements obtained with the SPECT and PET imaging scans. Measurements such as myocardial blood flow (MBF) and myocardial flow reserve (MFR) are analyzed on PET scans. These measurements give the doctors more precise information in diagnosing heart problems. SPECT scans, with new camera technology and computer software, now have the potential to also give this additional information. The study is investigating how well the blood flow measurements from SPECT compared to PET.

Detailed description

Absolute myocardial blood flow (MBF) and myocardial flow reserve (MFR) are calculated measurements that are obtained using positron emission tomography (PET) nuclear imaging, from a myocardial perfusion imaging (MPI) stress test, due to the advanced capabilities of the PET camera technology. These calculations provide more diagnostic and prognostic information for patients. Single photon emission computed tomography (SPECT) nuclear imaging is more widely done due to the availability and lower costs, but in the past has not been able to provide the additional information needed to perform the MBF and MFR calculations. SPECT cameras have now been developed and are in use, as well as software for the cameras that have shown that these measurements can be obtained from SPECT. The goal of this study is to compare SPECT and PET measurement of MBF and MFR and determine the reproducibility of SPECT MFR measurements. The study will be done in 3 Phases, with recruitment done over 3 years. Phase 1 and 2 will be done over the first 2 years, with Phase 3 planned following Phases 1 and 2, in the 3rd year of recruitment. Phase 1: patients with coronary artery disease, who are coming to the University of Ottawa Heart Institute (UOHI) for MPI stress testing will have both a PET and SPECT MPI for comparison of the measurements of MBF and MFR. The PET scan will be done as the clinical, reportable test. Phase 2: patients with coronary artery disease, who are coming to UOHI for SPECT MPI testing will have the SPECT repeated to see how reproducible the measurements are. Phase 3: normal, healthy volunteers will have both a PET and SPECT scan for the comparison of the measurements of MBF and MFR. No change to any patient care will be done in Phases 1 and 2. Phase 1 and Phase 2 participants will have 1 research scan and Phase 3 participants will have 2 research scans. Rubidium (Rb-82) Elution System Performance Data will be collected on the elution pump system, used to deliver the Rb-82 isotope, to support the system performance documentation for Health Canada Authorization.

Conditions

Interventions

TypeNameDescription
OTHERsingle photon emission computed tomographySingle photon emission computed tomography (SPECT) imaging will be done.

Timeline

Start date
2014-10-30
Primary completion
2022-09-02
Completion
2022-09-02
First posted
2014-11-03
Last updated
2025-04-06
Results posted
2025-04-06

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT02280941. Inclusion in this directory is not an endorsement.