Back to resultsRubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
Primary Purpose
Coronary Artery Disease
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Rubidium-82
Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium
Eligibility Criteria
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
Sites / Locations
- University College Hospital London NHS Foundation Trust
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single arm
Arm Description
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.
Outcomes
Primary Outcome Measures
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
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).
Secondary Outcome Measures
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Full Information
NCT ID
NCT01379677
First Posted
June 9, 2011
Last Updated
May 13, 2014
Sponsor
Advanced Accelerator Applications
1. Study Identification
Unique Protocol Identification Number
NCT01379677
Brief Title
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
Official Title
Diagnosis of Coronary Artery Disease With Rubidium-82 PET and Technetium-99m-MIBI SPET: A Head to Head Comparison, Versus Coronary CT Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
February 2011 (undefined)
Primary Completion Date
November 2013 (Actual)
Study Completion Date
November 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Advanced Accelerator Applications
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single arm
Arm Type
Other
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rubidium-82
Other Intervention Name(s)
CardioGen-82
Intervention Description
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
Intervention Type
Drug
Intervention Name(s)
Sestamibi. reconstitution with sodium pertechnetate (99mTc)
Other Intervention Name(s)
Technescan MIBI
Intervention Description
Maximum dose allowed per injection: 1000 MBq Intravenous Use
Primary Outcome Measure Information:
Title
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
Description
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).
Time Frame
Up to 2 days
Secondary Outcome Measure Information:
Title
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Time Frame
Up to 2 days
Title
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time Frame
Up to 2 days
Title
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
Title
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Time Frame
Up to 2 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leon Menezes, Dr.
Organizational Affiliation
University College Hospital London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College Hospital London NHS Foundation Trust
City
London
ZIP/Postal Code
NW1 2BU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
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