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Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

This study has suspended participant recruitment.
(Difficulty producing tracer)
Sponsor:
Collaborator:
Guy's and St Thomas' NHS Foundation Trust
Information provided by (Responsible Party):
Matthew Waltham, King's College London
ClinicalTrials.gov Identifier:
NCT01000181
First received: October 21, 2009
Last updated: April 5, 2012
Last verified: April 2012
History of Changes
  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

Resource links provided by NLM:

MedlinePlus related topics: Atherosclerosis
U.S. FDA Resources

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

Primary Outcome Measures:
  • Uptake of CuATSM in carotid plaque [ Time Frame: Within 30 days of carotid endarterectomy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Relationship of CuATSM uptake to plaque histology [ Time Frame: Within 30 days of carotid endarterectomy ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 21, 2009
Last Updated: April 5, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Atherosclerosis
Carotid Artery Diseases
Carotid Stenosis
Plaque, Atherosclerotic
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
 Cardiovascular Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on May 16, 2013