Reducing Radioisotope Dose: the Half-Dose CZT Study

NCT01518777 | Completed

• 1 other identifier: Pro00006818
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Image quality of the half-dose CZT versus full dose scans

  1 Week

Secondary Outcomes (4)

• Total radiation dose/exposure of the half-dose CZT vs. full dose scans

  1 Week

• Total myocardial count activity and count rates obtained during each scan

  1 Week

• 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

  1 Week

• 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

  1 Week

Study Arms (1)

Half-dose isotope for NuclearStressTest

OTHER

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.

Other: Half-dose isotope for NuclearStressTest

Interventions

Half-dose isotope for NuclearStressTest OTHER

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.

Also known as: SPECT using CZT

Half-dose isotope for NuclearStressTest

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age and referred for a clinically-indicated stress SPECT MPI study
• suspected or known coronary artery disease
• written informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• S.M.Chang, MD: lead
• The Methodist Hospital Research Institute: collaborator

Study Sites (1)

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (16)

• Shaw LJ, Iskandrian AE. Prognostic value of gated myocardial perfusion SPECT. J Nucl Cardiol. 2004 Mar-Apr;11(2):171-85. doi: 10.1016/j.nuclcard.2003.12.004. No abstract available.

  PMID: 15052249 BACKGROUND

• 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. doi: 10.1016/j.nuclcard.2006.08.011. No abstract available.

  PMID: 17174798 BACKGROUND

• 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. doi: 10.1161/CIRCULATIONAHA.107.688101. No abstract available.

  PMID: 17846343 BACKGROUND

• 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. doi: 10.1001/jama.298.3.317.

  PMID: 17635892 BACKGROUND

• 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. doi: 10.1056/NEJMoa0901249.

  PMID: 19710483 BACKGROUND

• Fazel R, Shaw LJ. Radiation exposure from radionuclide myocardial perfusion imaging: concerns and solutions. J Nucl Cardiol. 2011 Aug;18(4):562-5. doi: 10.1007/s12350-011-9403-y. No abstract available.

  PMID: 21638151 BACKGROUND

• 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. doi: 10.2967/jnumed.109.065532. Epub 2009 Dec 15.

  PMID: 20008999 BACKGROUND

• 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. doi: 10.1007/s00259-009-1375-7. Epub 2010 Jan 27.

  PMID: 20107783 BACKGROUND

• 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. doi: 10.1007/s12350-009-9137-2. Epub 2009 Aug 18.

  PMID: 19688410 BACKGROUND

• 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. doi: 10.1161/CIRCIMAGING.110.957399. Epub 2010 Nov 10.

  PMID: 21068188 BACKGROUND

• 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. doi: 10.1007/s12350-011-9379-7. Epub 2011 Apr 29.

  PMID: 21528422 BACKGROUND

• 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. doi: 10.1007/s12350-011-9382-z. Epub 2011 Jun 3.

  PMID: 21638154 BACKGROUND

• 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. doi: 10.1016/j.nuclcard.2004.05.003.

  PMID: 15295415 BACKGROUND

• 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. doi: 10.1016/j.icrp.2008.08.003.

  PMID: 19154964 BACKGROUND

• The 2007 Recommendations of the International Commission on Radiological Protection. ICRP publication 103. Ann ICRP. 2007;37(2-4):1-332. doi: 10.1016/j.icrp.2007.10.003.

  PMID: 18082557 BACKGROUND

• Radiation dose to patients from radiopharmaceuticals (addendum 2 to ICRP publication 53). Ann ICRP. 1998;28(3):1-126. doi: 10.1016/s0146-6453(99)00006-8.

  PMID: 10840563 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Su Min Chang, MD

  The Methodist Hospital Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sponsor-Investigator/Principal Investigator

Study Record Dates

• First Submitted: January 23, 2012
• First Posted: January 26, 2012
• Study Start: January 1, 2012
• Primary Completion: December 16, 2016
• Study Completion: December 16, 2016
• Last Updated: September 6, 2019

Record last verified: 2019-09

Locations

US (1)