Reducing Radioisotope Dose: the Half-Dose CZT Study - Full Text View

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:

MedlinePlus related topics: Coronary Artery Disease Nuclear Scans

Drug Information available for: Cadmium

U.S. FDA Resources

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:

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:

Shaw LJ, Iskandrian AE. Prognostic value of gated myocardial perfusion SPECT. J Nucl Cardiol. 2004 Mar-Apr;11(2):171-85. Review. No abstract available.

Henzlova MJ, Cerqueira MD, Mahmarian JJ, Yao SS; Quality Assurance Committee of the American Society of Nuclear Cardiology. Stress protocols and tracers. J Nucl Cardiol. 2006 Nov;13(6):e80-90. No abstract available.

Einstein AJ, Moser KW, Thompson RC, Cerqueira MD, Henzlova MJ. Radiation dose to patients from cardiac diagnostic imaging. Circulation. 2007 Sep 11;116(11):1290-305. Review. No abstract available.

Einstein AJ, Henzlova MJ, Rajagopalan S. Estimating risk of cancer associated with radiation exposure from 64-slice computed tomography coronary angiography. JAMA. 2007 Jul 18;298(3):317-23.

Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, Shah ND, Nasir K, Einstein AJ, Nallamothu BK. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med. 2009 Aug 27;361(9):849-57.

Fazel R, Shaw LJ. Radiation exposure from radionuclide myocardial perfusion imaging: concerns and solutions. J Nucl Cardiol. 2011 Aug;18(4):562-5. Review. No abstract available.

Herzog BA, Buechel RR, Katz R, Brueckner M, Husmann L, Burger IA, Pazhenkottil AP, Valenta I, Gaemperli O, Treyer V, Kaufmann PA. Nuclear myocardial perfusion imaging with a cadmium-zinc-telluride detector technique: optimized protocol for scan time reduction. J Nucl Med. 2010 Jan;51(1):46-51. Epub 2009 Dec 15.

Buechel RR, Herzog BA, Husmann L, Burger IA, Pazhenkottil AP, Treyer V, Valenta I, von Schulthess P, Nkoulou R, Wyss CA, Kaufmann PA. Ultrafast nuclear myocardial perfusion imaging on a new gamma camera with semiconductor detector technique: first clinical validation. Eur J Nucl Med Mol Imaging. 2010 Apr;37(4):773-8. Epub 2010 Jan 27. Erratum in: Eur J Nucl Med Mol Imaging. 2011 Jun;38(6):1172.

Esteves FP, Raggi P, Folks RD, Keidar Z, Askew JW, Rispler S, O'Connor MK, Verdes L, Garcia EV. Novel solid-state-detector dedicated cardiac camera for fast myocardial perfusion imaging: multicenter comparison with standard dual detector cameras. J Nucl Cardiol. 2009 Nov-Dec;16(6):927-34. Epub 2009 Aug 18.

Gimelli A, Bottai M, Giorgetti A, Genovesi D, Kusch A, Ripoli A, Marzullo P. Comparison between ultrafast and standard single-photon emission CT in patients with coronary artery disease: a pilot study. Circ Cardiovasc Imaging. 2011 Jan;4(1):51-8. Epub 2010 Nov 10.

Duvall WL, Croft LB, Ginsberg ES, Einstein AJ, Guma KA, George T, Henzlova MJ. Reduced isotope dose and imaging time with a high-efficiency CZT SPECT camera. J Nucl Cardiol. 2011 Oct;18(5):847-57. Epub 2011 Apr 29.

Duvall WL, Sweeny JM, Croft LB, Barghash MH, Kulkarni NK, Guma KA, Henzlova MJ. Comparison of high efficiency CZT SPECT MPI to coronary angiography. J Nucl Cardiol. 2011 Aug;18(4):595-604. Epub 2011 Jun 3.

Mahmarian JJ, Shaw LJ, Olszewski GH, Pounds BK, Frias ME, Pratt CM; INSPIRE Investigators. Adenosine sestamibi SPECT post-infarction evaluation (INSPIRE) trial: A randomized, prospective multicenter trial evaluating the role of adenosine Tc-99m sestamibi SPECT for assessing risk and therapeutic outcomes in survivors of acute myocardial infarction. J Nucl Cardiol. 2004 Jul-Aug;11(4):458-69.

ICRP. Radiation dose to patients from radiopharmaceuticals. Addendum 3 to ICRP Publication 53. ICRP Publication 106. Approved by the Commission in October 2007. Ann ICRP. 2008;38(1-2):1-197.

[No authors listed] The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332.

[No authors listed] Radiation dose to patients from radiopharmaceuticals (addendum 2 to ICRP publication 53). Ann ICRP. 1998;28(3):1-126.

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 May 16, 2013