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Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01000181
Recruitment Status : Suspended (Difficulty producing tracer)
First Posted : October 22, 2009
Last Update Posted : April 6, 2012
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Matthew Waltham, King's College London

Brief 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. 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.

Condition or disease Intervention/treatment
Carotid Atherosclerosis Other: PET-CT with CuATSM

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque
Study Start Date : October 2012

Group/Cohort Intervention/treatment
Patients undergoing carotid endarterectomy Other: PET-CT with CuATSM

Primary Outcome Measures :
  1. Uptake of CuATSM in carotid plaque [ Time Frame: Within 30 days of carotid endarterectomy ]

Secondary Outcome Measures :
  1. Relationship of CuATSM uptake to plaque histology [ Time Frame: Within 30 days of carotid endarterectomy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients undergoing carotid endarterectomy

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01000181

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United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
King's College London
Guy's and St Thomas' NHS Foundation Trust
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Principal Investigator: Matt Waltham, MA PhD King's College London
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Responsible Party: Matthew Waltham, Senior Lecturer, King's College London Identifier: NCT01000181    
Other Study ID Numbers: KCLADS09/1
GSTT Charity 251983
EudraCT 2009-011476-30
First Posted: October 22, 2009    Key Record Dates
Last Update Posted: April 6, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Carotid Artery Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases