Reducing Radioisotope Dose: the Half-Dose CZT Study

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014