Reducing Radioisotope Dose: the Half-Dose CZT Study

Not Applicable

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: Half-dose isotope for NuclearStressTest

• Registration Number: NCT01518777
• Lead Sponsor: S.M.Chang, MD

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-01-23
• Study First Submitted QC: 2012-01-25
• Study First Posted: 2012-01-26
• Primary Completion: 2016-12-16
• Study Completion: 2016-12-16
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-04
• Last Update Posted: 2019-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Half-dose isotope for NuclearStressTest	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.

Primary Outcome Measures

Name	Time	Method
Image quality of the half-dose CZT versus full dose scans	1 Week

Secondary Outcome Measures

Name	Time	Method
Total radiation dose/exposure of the half-dose CZT vs. full dose scans	1 Week
Total myocardial count activity and count rates obtained during each scan	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	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	1 Week

Trial Locations

Locations (1)

Houston Methodist Hospital; 🇺🇸 Houston, Texas, United States