Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

April 5, 2012 updated by: Matthew Waltham, King's College London

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.

Study Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing carotid endarterectomy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Uptake of CuATSM in carotid plaque
Time Frame: Within 30 days of carotid endarterectomy
Within 30 days of carotid endarterectomy

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship of CuATSM uptake to plaque histology
Time Frame: Within 30 days of carotid endarterectomy
Within 30 days of carotid endarterectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

Guy's and St Thomas' NHS Foundation Trust

Investigators

  • Principal Investigator: Matt Waltham, MA PhD, King's College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Study Registration Dates

First Submitted

October 21, 2009

First Submitted That Met QC Criteria

October 21, 2009

First Posted (Estimate)

October 22, 2009

Study Record Updates

Last Update Posted (Estimate)

April 6, 2012

Last Update Submitted That Met QC Criteria

April 5, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KCLADS09/1
  • GSTT Charity 251983
  • EudraCT 2009-011476-30

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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