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Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

This study has suspended participant recruitment.
(Difficulty producing tracer)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01000181
First Posted: October 22, 2009
Last Update Posted: April 6, 2012
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.
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Matthew Waltham, King's College London
  Purpose
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 Intervention
Carotid Atherosclerosis Other: PET-CT with CuATSM

Study Type: Observational
Study Design: 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

Further study details as provided by Matthew Waltham, King's College London:

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

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

Estimated Enrollment: 10
Study Start Date: October 2012
Groups/Cohorts Assigned Interventions
Patients undergoing carotid endarterectomy Other: PET-CT with CuATSM
PET-CT with CuATSM

  Eligibility

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01000181


Locations
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
Investigators
Principal Investigator: Matt Waltham, MA PhD King's College London
  More Information

Responsible Party: Matthew Waltham, Senior Lecturer, King's College London
ClinicalTrials.gov Identifier: NCT01000181     History of Changes
Other Study ID Numbers: KCLADS09/1
GSTT Charity 251983
EudraCT 2009-011476-30
First Submitted: October 21, 2009
First Posted: October 22, 2009
Last Update Posted: April 6, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases