Coronary Artery DiseasePhase 3NCT01379677
Rubidium-82 PET and Tc-99m-MIBI SPET: A Head to Head Comparison
A Phase 3 study testing Rubidium-82 and Sestamibi. reconstitution with sodium pertechnetate (99mTc) in people with Coronary Artery Disease, run by Advanced Accelerator Applications at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Rubidium-82 and Sestamibi. reconstitution with sodium pertechnetate (99mTc)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2011to Nov 2013
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
Who cannot join
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University College Hospital London NHS Foundation Trust
London, London, NW1 2BU
About this study
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
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).
- Conditions
- Coronary Artery Disease
- Being tested
- Rubidium-82, Sestamibi. reconstitution with sodium pertechnetate (99mTc)
- Keywords
- Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rubidium-82Drug
Also called CardioGen-82
Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
Sestamibi. reconstitution with sodium pertechnetate (99mTc)Drug
Also called Technescan MIBI
Maximum dose allowed per injection: 1000 MBq Intravenous Use
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Other | 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. Receives: Drug: Rubidium-82; Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Up to 2 days
Secondary outcomes (4)
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Measured: Up to 2 days
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Measured: Up to 2 days
Evaluate any difference in image quality, artefacts and interpretative confidence between Rubidium-82 PET and Tc-99m-MIBI SPET.
Measured: Up to 2 days
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Measured: Up to 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2011 (estimated)
- Study startFeb 2011
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Advanced Accelerator Applications
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leon Menezes, Dr., Principal investigator, University College Hospital London NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01379677
- Sponsor's protocol ID
- 2009Rb82UK
- Other IDs
- 2009-016645-25, 2009
- Status last verified
- May 2014
- First submitted
- 9 Jun 2011
- Last updated
- 14 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01379677
- Acronym / sponsor ID
- 2009Rb82UK
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Disease, Myocardial perfusion imaging, Rubidium, Technetium
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Advanced Accelerator ApplicationsIndustry (pharma, biotech, devices)
- Study start
- Feb 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Other | Drug: Rubidium-82, Drug: Sestamibi. reconstitution with sodium pertechnetate (99mTc)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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Referred for scintigraphy to assess myocardial ischaemia
- Ability to give informed written consent.
Key exclusion criteria (6 listed)
- Impaired capacity to consent
- Pregnancy, or breastfeeding
- Allergy to iv contrast
- Renal failure
- Severe Uncontrolled asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rubidium-82Also: CardioGen-82Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use | Drug | Single arm |
| Sestamibi. reconstitution with sodium pertechnetate (99mTc)Also: Technescan MIBIMaximum dose allowed per injection: 1000 MBq Intravenous Use | Drug | Single arm |
Primary outcome
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography)
Time frame: Up to 2 days
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).
4 secondary outcomes
Evaluate any difference in the clinical interpretation of the Rubidium-82 PET and Tc-99m-MIBI SPET images.
Time frame: Up to 2 days
Evaluate any difference in "Percentage myocardium" that is hypoperfused, between Rubidium-82 PET and Tc-99m-MIBI SPET.
Time frame: Up to 2 days
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
Evaluate any adverse events or reactions, during Rubidum-82 or Tc-MIBI administration.
Time frame: Up to 2 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leon Menezes, Dr. principal investigator
University College Hospital London NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Rubidium-82 and Sestamibi. reconstitution with sodium pertechnetate (99mTc) in people with Coronary Artery Disease, run by Advanced Accelerator Applications at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The specificity of detecting significant coronary artery disease (as defined as being >70% stenosis, on coronary CT angiography) (time frame: Up to 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2014.