NCT01000181

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.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial recruitment is currently suspended
Enrollment
10

participants targeted

Target at below P25 for all trials

Geographic Reach
1 country

1 active site

Status
suspended

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2009

Completed
2.9 years until next milestone

Study Start

First participant enrolled

October 1, 2012

Completed
Last Updated

April 6, 2012

Status Verified

April 1, 2012

First QC Date

October 21, 2009

Last Update Submit

April 5, 2012

Conditions

Carotid Atherosclerosis

Outcome Measures

Primary Outcomes (1)

  • Uptake of CuATSM in carotid plaque

    Within 30 days of carotid endarterectomy

Secondary Outcomes (1)

  • Relationship of CuATSM uptake to plaque histology

    Within 30 days of carotid endarterectomy

Study Arms (1)

Patients undergoing carotid endarterectomy

Other: PET-CT with CuATSM

Interventions

PET-CT with CuATSMOTHER

PET-CT with CuATSM

Patients undergoing carotid endarterectomy

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing carotid endarterectomy

You may qualify if:

  • 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

You may not qualify if:

  • Abnormal liver and renal function (eGFR \<50ml/min, Creatinine \>130μmol/L)
  • Patient unwilling to provide written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Thomas' Hospital

London, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Carotid Artery Diseases

Interventions

CuATSM

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Matt Waltham, MA PhD

    King's College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Lecturer

Study Record Dates

First Submitted

October 21, 2009

First Posted

October 22, 2009

Study Start

October 1, 2012

Last Updated

April 6, 2012

Record last verified: 2012-04

Locations

GB(1)