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Reducing Radioisotope Dose: the Half-Dose CZT Study

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Half-dose isotope for NuclearStressTest

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Houston Methodist Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Half-dose isotope for NuclearStressTest

Arm Description

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.

Outcomes

Primary Outcome Measures

Image quality of the half-dose CZT versus full dose scans

Secondary Outcome Measures

Total radiation dose/exposure of the half-dose CZT vs. full dose scans

Total myocardial count activity and count rates obtained during each scan

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

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

Full Information

NCT ID

NCT01518777

First Posted

January 23, 2012

Last Updated

September 4, 2019

Sponsor

S.M.Chang, MD

Collaborators

The Methodist Hospital Research Institute

1. Study Identification

Unique Protocol Identification Number

NCT01518777

Brief Title

Reducing Radioisotope Dose: the Half-Dose CZT Study

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

January 2012 (undefined)

Primary Completion Date

December 16, 2016 (Actual)

Study Completion Date

December 16, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

S.M.Chang, MD

Collaborators

The Methodist Hospital Research Institute

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary Artery Disease

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

74 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Half-dose isotope for NuclearStressTest

Arm Type

Other

Arm Description

Intervention Type

Other

Intervention Name(s)

Half-dose isotope for NuclearStressTest

Other Intervention Name(s)

SPECT using CZT

Intervention Description

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.

Primary Outcome Measure Information:

Title

Image quality of the half-dose CZT versus full dose scans

Time Frame

1 Week

Secondary Outcome Measure Information:

Title

Total radiation dose/exposure of the half-dose CZT vs. full dose scans

Time Frame

1 Week

Title

Total myocardial count activity and count rates obtained during each scan

Time Frame

1 Week

Title

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

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Su Min Chang, MD

Organizational Affiliation

The Methodist Hospital Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Houston Methodist Hospital

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

IPD Sharing Plan Description

No.

Citations:

PubMed Identifier

15052249

Citation

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Citation

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Citation

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Reducing Radioisotope Dose: the Half-Dose CZT Study

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