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Completed

NCT Number: NCT01518777

Reducing Radioisotope Dose: the Half-Dose CZT Study

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

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Houston Methodist Hospital

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Half-dose isotope for NuclearStressTest

Other

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

Primary outcomes

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

    Time frame: 1 Week

Secondary outcomes

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

    Time frame: 1 Week

  2. Total myocardial count activity and count rates obtained during each scan

    Time frame: 1 Week

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

S.M.Chang, MD

Other

Collaborators

  • The Methodist Hospital Research Institute

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Jan 26, 2012
Registry last updated
Sep 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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