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Reducing Radioisotope Dose: the Half-Dose CZT Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by The Methodist Hospital System
Sponsor:
Collaborator:
Houston Methodist Research Institute
Information provided by (Responsible Party):
S.M.Chang, MD, The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01518777
First received: January 23, 2012
Last updated: September 16, 2016
Last verified: September 2016

January 23, 2012
September 16, 2016
January 2012
December 2016   (final data collection date for primary outcome measure)
Image quality of the half-dose CZT versus full dose scans [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01518777 on ClinicalTrials.gov Archive Site
  • Total radiation dose/exposure of the half-dose CZT vs. full dose scans [ Time Frame: 1 Week ] [ Designated as safety issue: Yes ]
  • Total myocardial count activity and count rates obtained during each scan [ Time Frame: 1 Week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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
This is a pilot study to see whether cardiac imaging can be performed using half the standard dose of radioisotope.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
Other: Half-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.
Other Name: SPECT using CZT
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.
Intervention: Other: Half-dose isotope for NuclearStressTest

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
November 2017
December 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years   (Adult, Senior)
No
Contact: Christopher Mattair 713-363-9956 cbmattair@houstonmethodist.og
United States
 
NCT01518777
Pro00006818
No
Undecided
To be determined.
S.M.Chang, MD, The Methodist Hospital System
S.M.Chang, MD
Houston Methodist Research Institute
Principal Investigator: Su Min Chang, MD The Methodist Hospital System
The Methodist Hospital System
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP