Improve Nuclear Medicine Heart Imaging, Compare MRI Results With Single Photon Emission Computed Tomography Imaging

December 13, 2023 updated by: Andrzej Krol, State University of New York - Upstate Medical University

Evaluation of EM-IntraSPECT Reconstruction Algorithm by Comparison of Transmission Images Reconstructed From SPECT Projections Alone With MRI Studies

The purpose of this study is to compare the MRI results with the new SPECT image reconstruction method, this study will allow us to determine whether a new more accurate method of looking at the heart by nuclear study can be used in routine clinical use.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Currently, up to one-third of all nuclear medicine studies are performed for cardiovascular disorders, and mostly are myocardial perfusion imaging (MPI) using SPECT acquisition. MPI aims at detection of acute myocardial ischemia and the scarred myocardium and it is increasingly used to plan myocardial revascularization and to assess the effectiveness of medical and surgical interventions. However, nonuniform gamma-ray attenuation in the thoracic region may severely impair the accuracy of SPECT cardiac imaging and frequently result in image artifacts. Therefore, attenuation corrected must be applied. We have derived an algorithm (called EM-IntraSPECT) that is able to reconstruct tomographic cross-sections of a patient from SPECT studies alone. The reconstructed cross-sections in turn, may be used for attenuation correction of cardiac SPECT images thus improving quality analysis based of these images. In this research we intend to continue evaluation of the new attenuation compensation algorithm and to assess the clinical usefulness of this method. These goals can be reached by comparing the patient's cross sectional anatomical data reconstructed by EM-IntraSPECT and obtained from MRI. It is proposed that 10 patients already undergoing nuclear cardiac imaging for clinical purpose, with 99mTc sestamibi or 99mTc radiolabeled red cells will be selected. These patients would be utilized to reconstruct transmission images and determination of internal anatomical structures in the thoracic region from SPECT projections alone. Further, direct and quantitative comparison of the patient's anatomy obtained by the MRI and the SPECT methods will be performed. The same algorithm would be used for reconstruction of attenuation compensated emission SPECT cardiac images. Finally, the accuracy and the clinical usefulness of this new, attenuation corrected cardiac SPECT image reconstruction would be quantitatively evaluated. All these procedures apply only to the image data and NOT the patient.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Subjects who are being evaluated for cardiac function/perfusion

Description

Inclusion Criteria:

  • subjects scheduled for cardiac SPECT
  • subjects 18 years old or older

Exclusion Criteria:

  • Females who are pregnant or think that they are pregnant will be excluded in this study.
  • Subjects who have a pacemaker, internal defibrillator, prostheses, artificial heart valves, cardiac stents, surgical clips, or TENS (transcutaneous electric nerve stimulator)
  • Subjects who are 300 lbs and over

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
State University of New York - Upstate Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrzej Krol, PhD, State University of New York - Upstate Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 1996

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2008

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2008

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 14, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 13, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SUNYUMU 3257

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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