Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

NCT ID: NCT01000181

Last Updated: 2012-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Carotid Atherosclerosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients undergoing carotid endarterectomy

PET-CT with CuATSM

Intervention Type OTHER

PET-CT with CuATSM

Interventions

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PET-CT with CuATSM

PET-CT with CuATSM

Intervention Type OTHER

Eligibility 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
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College London

OTHER

Sponsor Role lead

Responsible Party

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Matthew Waltham

Senior Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matt Waltham, MA PhD

Role: PRINCIPAL_INVESTIGATOR

King's College London

Locations

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St Thomas' Hospital

London, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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GSTT Charity 251983

Identifier Type: -

Identifier Source: secondary_id

EudraCT 2009-011476-30

Identifier Type: -

Identifier Source: secondary_id

KCLADS09/1

Identifier Type: -

Identifier Source: org_study_id

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