- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01379677
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
May 13, 2014 updated by: Advanced Accelerator Applications
Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
The main purpose of this study is to compare myocardial perfusion imaging using Rubidium-82 PET with Tc-99m-MIBI SPET, in the evaluation of significant Coronary Artery Disease (CAD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
135
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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London, United Kingdom, NW1 2BU
- University College Hospital London NHS Foundation Trust
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
Exclusion Criteria:
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
- Claustrophobia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Single arm
This is an Head to Head Comparison between Rubidium-82 PET and Tc-99m-MIBI SPET with CTA as gold standard.
All the patients will undergo the three imaging protocols.
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Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
Other Names:
Maximum dose allowed per injection: 1000 MBq Intravenous Use
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
Time Frame: Up to 2 days
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The primary objective is to compare PET vs. SPET, with the primary outcome being the specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography).
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Up to 2 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Time Frame: Up to 2 days
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Up to 2 days
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Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time Frame: Up to 2 days
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Up to 2 days
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Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time Frame: Up to 2 days
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Up to 2 days
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Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Time Frame: Up to 2 days
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Up to 2 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Leon Menezes, Dr., University College Hospital London NHS Foundation Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2011
Primary Completion (Actual)
November 1, 2013
Study Completion (Actual)
November 1, 2013
Study Registration Dates
First Submitted
June 9, 2011
First Submitted That Met QC Criteria
June 22, 2011
First Posted (Estimate)
June 23, 2011
Study Record Updates
Last Update Posted (Estimate)
May 14, 2014
Last Update Submitted That Met QC Criteria
May 13, 2014
Last Verified
May 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2009Rb82UK
- 2009-016645-25 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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