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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01000181 |
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Date of registration:
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21/10/2009 |
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Primary sponsor: |
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Public title:
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Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT
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Scientific title:
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A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque |
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Date of first enrolment:
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October 2012 |
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Target sample size:
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10 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT01000181 |
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Study type:
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Observational |
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Study design:
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Observational Model: Case-Only, Time Perspective: Prospective
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Matt Waltham, MA PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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King's College London |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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
Exclusion Criteria:
- Abnormal liver and renal function (eGFR <50ml/min, Creatinine >130µmol/L)
- Patient unwilling to provide written informed consent
Age minimum:
55 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Carotid Atherosclerosis
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Intervention(s)
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Other: PET-CT with CuATSM
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Primary Outcome(s)
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Uptake of CuATSM in carotid plaque
[Time Frame: Within 30 days of carotid endarterectomy]
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Secondary Outcome(s)
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Relationship of CuATSM uptake to plaque histology
[Time Frame: Within 30 days of carotid endarterectomy]
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Secondary ID(s)
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EudraCT 2009-011476-30
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GSTT Charity 251983
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KCLADS09/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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