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Reducing Radioisotope Dose: the Half-Dose CZT Study

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01518777
Enrollment
74
Registered
2012-01-26
Start date
2012-01-31
Completion date
2016-12-16
Last updated
2019-09-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease

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.

Interventions

OTHERHalf-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.

Sponsors

The Methodist Hospital Research Institute
CollaboratorOTHER
S.M.Chang, MD
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Image quality of the half-dose CZT versus full dose scans1 Week

Secondary

MeasureTime frame
Total radiation dose/exposure of the half-dose CZT vs. full dose scans1 Week
Total myocardial count activity and count rates obtained during each scan1 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 basis1 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 volume1 Week

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026