Reducing Radioisotope Dose: the Half-Dose CZT Study

September 4, 2019 updated by: S.M.Chang, MD

Reducing Radioisotope Dose in Regadenoson SPECT Myocardial Perfusion Imaging: Comparison of Half-Dose Scans Using a Novel Solid-State-Detector Dedicated Cardiac Camera to Full Dose Scans Acquired On Standard Equipment

This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study is to compare the image quality of the half radioisotope dose scans obtained using a CZT (cadmium zinc telluride) camera with scans acquired using a standard of care imaging protocol/radioisotope dose performed on a traditional (conventional) camera.

The proposed strategy of a half dose/extended time protocol with the CZT camera should yield a similar count activity and consequently image quality equivalent to that detected by a conventional SPECT system.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

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
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

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

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study
  • suspected or known coronary artery disease
  • written informed consent

Exclusion Criteria:

  • Evidence of a normal baseline scan after at least 50% of the protocol acquired baseline scans have been interpreted as being normal
  • Participation in another investigational study within the preceding month
  • Pregnant and/or breast-feeding female
  • ECG evidence of left bundle branch block or paced rhythm
  • Evidence of non-ischemic cardiomyopathy
  • Presence of hypertrophic cardiomyopathy and/or severe valvular heart disease
  • Severe claustrophobia or inability to lie flat for 20 minutes (the anticipated amount of time to complete the procedure)
  • Known allergy to technetium-99m
  • Potential contraindications to regadenoson use, due to severe lung disease; severe bradycardia (heart rate < 40 beats/min); second- or third degree atrioventricular heart block; sick sinus syndrome; long QT syndrome; severe hypotension; or decompensated heart failure.

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

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Half-dose isotope for NuclearStressTest
Intervention is Nuclear stress test of the heart. Single-arm of this study "Half-dose of isotope for Nuclear stress test" is group of study subjects who will do Research Nuclear stress test with half-dose of isotope that normally used for routine Nuclear stress test. Isotope is the tracer CZT (cadmium zinc telluride) that used for Nuclear stress test routinely to see the function of arteries of the heart. Patients with suspected Coronary Artery Disease who meet entry criteria undergo a research nuclear stress test using a decreased dose of isotope, using a new camera.
Other: Half-dose isotope for NuclearStressTest
Half-dose of tracer or radioisotope will be used for Nuclear stress test of the heart. This is imaging test of the heart to see the function of arteries of the heart.
Other Names:
  • SPECT using CZT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Image quality of the half-dose CZT versus full dose scans
Time Frame: 1 Week
1 Week

Secondary Outcome Measures

Outcome Measure
Time Frame
Total radiation dose/exposure of the half-dose CZT vs. full dose scans
Time Frame: 1 Week
1 Week
Total myocardial count activity and count rates obtained during each scan
Time Frame: 1 Week
1 Week
Agreement between the half-dose CZT vs. full dose scans on the presence and extent of fixed or reversible defects on a per-patient and vessel basis
Time Frame: 1 Week
1 Week
Agreement between the half-dose vs. full dose scans on gated data such as EF, left ventricular (LV) end-diastolic volume, LV end-systolic volume
Time Frame: 1 Week
1 Week

Collaborators and Investigators

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

Sponsor

S.M.Chang, MD

Collaborators

The Methodist Hospital Research Institute

Investigators

  • Principal Investigator: Su Min Chang, MD, The Methodist Hospital Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

January 1, 2012

Primary Completion (Actual)

December 16, 2016

Study Completion (Actual)

December 16, 2016

Study Registration Dates

First Submitted

January 23, 2012

First Submitted That Met QC Criteria

January 25, 2012

First Posted (Estimate)

January 26, 2012

Study Record Updates

Last Update Posted (Actual)

September 6, 2019

Last Update Submitted That Met QC Criteria

September 4, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00006818

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

No.

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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