Reducing Radioisotope Dose: the Half-Dose CZT Study

This study is not yet open for participant recruitment.
Verified January 2012 by The Methodist Hospital System
Sponsor:
Information provided by (Responsible Party):
The Methodist Hospital System
ClinicalTrials.gov Identifier:
NCT01518777
First received: January 23, 2012
Last updated: January 25, 2012
Last verified: January 2012
  Purpose

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


Condition Intervention
Coronary Artery Disease
Radiation: Comparison of the image quality of the half-dose (cadmium zinc telluride) CZT versus full dose scans

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official 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

Resource links provided by NLM:


Further study details as provided by The Methodist Hospital System:

Primary Outcome Measures:
  • Image quality of the half-dose CZT versus full dose scans [ Time Frame: 1 Week ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Radiation: Comparison of the image quality of the half-dose (cadmium zinc telluride) CZT versus full dose scans
    Half the standard radioisotope dose used in conventional imaging will be administered to patients undergoing a CZT SPECT over an extended period of time in comparison to patients receiving a standard full radioisotope dose scan performed on a conventional SPECT camera.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01518777

Contacts
Contact: Glenda Santua, RN 713-441-3914 gksantua@tmhs.org

Locations
United States, Texas
The Methodist Hospital Not yet recruiting
Houston, Texas, United States, 77030
Contact: Glenda Santua, RN    713-441-3914    gksantua@tmhs.org   
Principal Investigator: John J Mahmarian, MD         
Sub-Investigator: Su-Min Chang, MD         
Sub-Investigator: Faisal Nabi, MD         
Sponsors and Collaborators
The Methodist Hospital System
Investigators
Principal Investigator: John J Mahmarian, MD The Methodist Hospital System
  More Information

Publications:

Responsible Party: The Methodist Hospital System
ClinicalTrials.gov Identifier: NCT01518777     History of Changes
Other Study ID Numbers: Pro00006818
Study First Received: January 23, 2012
Last Updated: January 25, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by The Methodist Hospital System:
Coronary Artery Disease

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 23, 2014