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Accuracy of Half of the Usual Radiotracer Dose in SPECT (SPECT-Light)

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
1/2 dose of 99mTc OR 201Tl tracers
Sponsored by
Ottawa Heart Institute Research Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Single-photon emission computed tomography, myocardial perfusion imaging, rest/stress, treadmill, persantine, half-dose, radiotracer, tetrofosmin, Thallium, cadmium zinc telluride, diagnostic, prognostic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Consecutive patients presenting for clinically indicated SPECT perfusion scan
  • Patients presenting to sites with a functional CZT camera. Available sites are Ottawa (OHI), Mississauga, and Calgary.
  • Age >18 years old

Exclusion Criteria:

  • Patients with a life expectancy less than 1 year, from non cardiac cause
  • Age < 18 years old or lack of consent
  • Allergy or contraindication to dipyridamole
  • Refractory angina or infarction or need for urgent angiography
  • Known pregnancy
  • Uncontrolled atrial fibrillation

Sites / Locations

  • University of Ottawa Heart Institute

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Comparison of radioisotope dosing

Arm Description

Outcomes

Primary Outcome Measures

Rate of non-fatal infarction or death in the normal group of SPECT-Light acquisitions versus standard SPECT acquisitions
The difference in the rate of non-fatal infarction or death that occurs in the normal group of the combined SPECT-Light acquisition protocols (LDa and LDb) versus the outcome that occurs in the acquisitions obtained by the standard SPECT (FD) protocol.

Secondary Outcome Measures

Comparison of classification of the degree of abnormality based on the two image acquisition protocols
A comparison of classification of the degree of abnormality based on the two image acquisition protocols. Multi-level correlation between the two image sets (LDa vs 2 and LDb vs 2) will be obtained against the standard SPECT (FD) images. The combined rates of non-fatal MI or death in each of the LD images as well as the standard dose images (FD) which are considered abnormal (SSS ≥ 4) will also be calculated.

Full Information

First Posted
August 7, 2011
Last Updated
February 23, 2016
Sponsor
Ottawa Heart Institute Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01412827
Brief Title
Accuracy of Half of the Usual Radiotracer Dose in SPECT
Acronym
SPECT-Light
Official Title
Diagnostic and Prognostic Accuracy of Stress SPECT Myocardial Perfusion Imaging With Half the Usual Radiotracer Dose
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ottawa Heart Institute Research Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
There has been a shortage of nuclear isotopes, not only in Canada but around the world. New, more sensitive SPECT cameras can obtain better images in shorter scan times. These cameras have also shown the ability to use a smaller dose of radioisotope to obtain the images. New software has been tested on the standard camera, the GE Infinia-Hawkeye SPECT/CT. The Diagnostic Imaging Department of The University of Ottawa Heart Institute has also acquired a new camera, the Discovery NM530c CZT and has been doing heart scans in shorter times. The investigators will now be looking at the quality of images using less isotope during SPECT myocardial perfusion imaging for diagnostic and prognostic purposes.
Detailed Description
SPECT MPI is well accepted as a reliable and cost-effective tool for diagnosis, risk stratification and management of patients with suspected or known coronary artery disease (CAD) (1;2). MPI represents approximately 40% of nuclear medicine patient studies and most of these use 99mTc-sestamibi or 99mTc-tetrofosmin(3). Rest/stress MPI using 99mTc-sestamibi and 99mTc-tetrofosmin uses more tracer doses than many other nuclear medicine tests and thus account for >50% of injected radiotracer activity(3). Thus, interruptions in the supply of 99Mo, the parent isotope of 99mTc, significantly affect stress MPI imaging and associated patient care. Alternatives to 99mTc-sestamibi and 99mTc-tetrofosmin for perfusion imaging include 201Tl for SPECT imaging and 82Rb or 13NH3 for positron emission tomography (PET) imaging (4;5). MPI using 201Tl has similar diagnostic accuracy but image interpretation is more difficult due to greater scatter and attenuation. Moreover, the patient effective radiation dose for MPI using a standard injected dose of 3.5mCi of 201Tl is ~20 mSv. This radiation dose is twice that of 99mTc tracers which typically deliver an effective dose of ~10 mSv. PET imaging with 82Rb or 13NH3 is another alternative, but is much more expensive and not routinely available in Canada due to a very limited install base of PET scanners and associated cyclotrons. The number of SPECT cameras operational in Canada is more than 40 times the number of PET scanners.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Single-photon emission computed tomography, myocardial perfusion imaging, rest/stress, treadmill, persantine, half-dose, radiotracer, tetrofosmin, Thallium, cadmium zinc telluride, diagnostic, prognostic

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Comparison of radioisotope dosing
Arm Type
Other
Intervention Type
Radiation
Intervention Name(s)
1/2 dose of 99mTc OR 201Tl tracers
Intervention Description
Rest: Imaging will occur 30 to 60 minutes after injection of tracer. Stress: All patients will undergo a symptom-limited Bruce protocol treadmill exercise test. At peak stress, the radiotracer will be injected intravenously, and exercise will continue for an additional 60 s. The patients who are unable to achieve the targeted heart rate or exercise will be stressed pharmacologically. Dipyridamole (0.142 mg/kg/min) will be infused intravenously for 5 minutes, and 99mTc radiotracer will be injected at 2 min after infusion completion (7 min into the study). Aminophylline (100-200 mg) will be given intravenously 2 min after injection of the radiotracer.
Primary Outcome Measure Information:
Title
Rate of non-fatal infarction or death in the normal group of SPECT-Light acquisitions versus standard SPECT acquisitions
Description
The difference in the rate of non-fatal infarction or death that occurs in the normal group of the combined SPECT-Light acquisition protocols (LDa and LDb) versus the outcome that occurs in the acquisitions obtained by the standard SPECT (FD) protocol.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Comparison of classification of the degree of abnormality based on the two image acquisition protocols
Description
A comparison of classification of the degree of abnormality based on the two image acquisition protocols. Multi-level correlation between the two image sets (LDa vs 2 and LDb vs 2) will be obtained against the standard SPECT (FD) images. The combined rates of non-fatal MI or death in each of the LD images as well as the standard dose images (FD) which are considered abnormal (SSS ≥ 4) will also be calculated.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Consecutive patients presenting for clinically indicated SPECT perfusion scan Patients presenting to sites with a functional CZT camera. Available sites are Ottawa (OHI), Mississauga, and Calgary. Age >18 years old Exclusion Criteria: Patients with a life expectancy less than 1 year, from non cardiac cause Age < 18 years old or lack of consent Allergy or contraindication to dipyridamole Refractory angina or infarction or need for urgent angiography Known pregnancy Uncontrolled atrial fibrillation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renée Hessian, MD
Organizational Affiliation
Ottawa Heart Institute Research Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa Heart Institute
City
Ottawa
State/Province
Ontario
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
14736438
Citation
Hachamovitch R, Hayes SW, Friedman JD, Cohen I, Berman DS. Stress myocardial perfusion single-photon emission computed tomography is clinically effective and cost effective in risk stratification of patients with a high likelihood of coronary artery disease (CAD) but no known CAD. J Am Coll Cardiol. 2004 Jan 21;43(2):200-8. doi: 10.1016/j.jacc.2003.07.043.
Results Reference
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PubMed Identifier
18202253
Citation
Marcassa C, Bax JJ, Bengel F, Hesse B, Petersen CL, Reyes E, Underwood R; European Council of Nuclear Cardiology (ECNC); European Society of Cardiology Working Group 5 (Nuclear Cardiology and Cardiac CT); European Association of Nuclear Medicine Cardiovascular Committee. Clinical value, cost-effectiveness, and safety of myocardial perfusion scintigraphy: a position statement. Eur Heart J. 2008 Feb;29(4):557-63. doi: 10.1093/eurheartj/ehm607. Epub 2008 Jan 17.
Results Reference
background
PubMed Identifier
17311116
Citation
Beanlands RS, Chow BJ, Dick A, Friedrich MG, Gulenchyn KY, Kiess M, Leong-Poi H, Miller RM, Nichol G, Freeman M, Bogaty P, Honos G, Hudon G, Wisenberg G, Van Berkom J, Williams K, Yoshinaga K, Graham J; Canadian Cardiovascular Society; Canadian Association of Radiologists; Canadian Association of Nuclear Medicine; Canadian Nuclear Cardiology Society; Canadian Society of Cardiac Magnetic Resonance. CCS/CAR/CANM/CNCS/CanSCMR joint position statement on advanced noninvasive cardiac imaging using positron emission tomography, magnetic resonance imaging and multidetector computed tomographic angiography in the diagnosis and evaluation of ischemic heart disease--executive summary. Can J Cardiol. 2007 Feb;23(2):107-19. doi: 10.1016/s0828-282x(07)70730-4.
Results Reference
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Accuracy of Half of the Usual Radiotracer Dose in SPECT

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