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

History of Changes

Tracking Information

First Received Date ^ICMJE

January 23, 2012

Last Updated Date

January 25, 2012

Start Date ^ICMJE

January 2012

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01518777 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Reducing Radioisotope Dose: the Half-Dose CZT Study

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

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.

Study Arm (s)

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

200

Estimated Completion Date

December 2014

Estimated Primary Completion Date

December 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Glenda Santua, RN

713-441-3914

gksantua@tmhs.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01518777

Other Study ID Numbers ^ICMJE

Pro00006818

Has Data Monitoring Committee

Responsible Party

The Methodist Hospital System

Study Sponsor ^ICMJE

The Methodist Hospital System

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

John J Mahmarian, MD

The Methodist Hospital System

Information Provided By

The Methodist Hospital System

Verification Date

January 2012

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

To Top