Carotid AtherosclerosisNCT01000181
Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT
An observational study of Carotid Atherosclerosis, run by King's College London at 1 site in United Kingdom.
Trial summary
The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. It is important to determine which patients are most at risk so that surgery can be performed. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Carotid Atherosclerosis
- What is being tested?
- PET-CT with CuATSM
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2012to not given
- Phase
- Observational
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing carotid endarterectomy
Who may be able to join
- Male/Female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy.
- Normal liver and adequate renal function. Assessed by measuring eGFR (>50ml/min) and creatinine (<130μmol/L)
- Life expectancy > 12 weeks
- Patients should be able to tolerate head/neck mask as well as lying in the PET-CT scanner
Who cannot join
- Abnormal liver and renal function (eGFR <50ml/min, Creatinine >130μmol/L)
- Patient unwilling to provide written informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque
The build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. It is important to determine which patients are most at risk so that surgery can be performed. There is evidence that the risk is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to use PET imaging to identify hypoxic plaque, to help decide whether and when to perform surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and this study is to determine whether they will work in patients.
- Conditions
- Carotid Atherosclerosis
- Being tested
- PET-CT with CuATSM
- Medical subject headings
- Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET-CT with CuATSMOther
PET-CT with CuATSM
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing carotid endarterectomy | Not described Receives: Other: PET-CT with CuATSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uptake of CuATSM in carotid plaque
Measured: Within 30 days of carotid endarterectomy
Secondary outcomes (1)
Relationship of CuATSM uptake to plaque histology
Measured: Within 30 days of carotid endarterectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startOct 2012
Why it stopped: Difficulty producing tracer
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid AtherosclerosisStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Responsible party
- Principal investigator, Matthew Waltham, King's College London
- Investigators
- Matt Waltham, MA PhD, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000181
- Sponsor's protocol ID
- KCLADS09/1
- Other IDs
- GSTT Charity 251983, EudraCT 2009-011476-30
- Status last verified
- Apr 2012
- First submitted
- 21 Oct 2009
- Last updated
- 6 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque
- ClinicalTrials.gov ID
- NCT01000181
- Acronym / sponsor ID
- KCLADS09/1
- Conditions
- Carotid Atherosclerosis
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Difficulty producing tracer
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- Guy's and St Thomas' NHS Foundation Trust
- Study start
- Oct 2012
- First posted
- 22 Oct 2009 (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 build up of plaque in the wall of the artery supplying blood to the brain poses a risk of stroke when the plaques become unstable and fragile. It is important to determine which patients are most at risk so that surgery can be performed. There is evidence that the risk is greatest when these plaques become oxygen deficient (hypoxic). The investigators wish to use PET imaging to identify hypoxic plaque, to help decide whether and when to perform surgery. The investigators have developed radiotracers (imaging agents) for this purpose, and this study is to determine whether they will work in patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing carotid endarterectomy | – | Other: PET-CT with CuATSM |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing carotid endarterectomy
Key inclusion criteria (4 listed)
- Male/Female patients who are 55yrs or older and for whom carotid endarterectomy is clinically indicated and a decision has been made to perform a carotid endarterectomy.
- Normal liver and adequate renal function. Assessed by measuring eGFR (>50ml/min) and creatinine (<130μmol/L)
- Life expectancy > 12 weeks
- Patients should be able to tolerate head/neck mask as well as lying in the PET-CT scanner
Key exclusion criteria (2 listed)
- Abnormal liver and renal function (eGFR <50ml/min, Creatinine >130μmol/L)
- Patient unwilling to provide written informed consent
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 |
|---|---|---|
| PET-CT with CuATSMPET-CT with CuATSM | Other | Patients undergoing carotid endarterectomy |
Primary outcome
Uptake of CuATSM in carotid plaque
Time frame: Within 30 days of carotid endarterectomy
1 secondary outcome
Relationship of CuATSM uptake to plaque histology
Time frame: Within 30 days of carotid endarterectomy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2012.
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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.
Matt Waltham, MA PhD principal investigator
King's College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Atherosclerosis, run by King's College London 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 4 inclusion and 2 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: paused, as of the sponsor's last update on 6 Apr 2012. 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.
Are results available for this study?
Results are not available in the source record.
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?
Uptake of CuATSM in carotid plaque (time frame: Within 30 days of carotid endarterectomy). 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 6 Apr 2012.