Reducing Radioisotope Dose: the Half-Dose CZT Study

S.M.Chang, MD

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: Half-dose isotope for NuclearStressTest

Study type: Interventional

Funder types: Other

Identifiers

NCT01518777

Pro00006818

Details and patient eligibility

About

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

Full 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.

Enrollment: 74 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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74 participants in 1 patient group

Half-dose isotope for NuclearStressTest

Other group

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.

Treatment:

Other: Half-dose isotope for NuclearStressTest