Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

Carotid Atherosclerosis Clinical Trial

Official title:

A Mechanistic, Non-randomised Study to Examine the Uptake of a Specific Radionuclide (61CuATSM) in Carotid Artery Plaque

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01000181
• Other study ID #: KCLADS09/1
• Secondary ID: GSTT Charity 251
• Status: Suspended
• Phase: N/A
• First received: October 21, 2009
• Last updated: April 5, 2012
• Start date: October 2012

Study information

• Verified date: April 2012
• Source: King's College London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 10
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atherosclerosis
• Carotid Artery Diseases
• Carotid Atherosclerosis

Intervention

Other:
• PET-CT with CuATSM
PET-CT with CuATSM

Locations

Country	Name	City	State
United Kingdom	St Thomas' Hospital	London

Sponsors (2)

Lead Sponsor	Collaborator
King's College London	Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Uptake of CuATSM in carotid plaque		Within 30 days of carotid endarterectomy	No
Secondary	Relationship of CuATSM uptake to plaque histology		Within 30 days of carotid endarterectomy	No