Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using P... | NCT01000181

Studies
Imaging 61CuATSM Uptake in Atherosclerotic Plaque Using PET-CT

NCT01000181

Sponsor

King's College London

Status

Suspended

Last Update Posted

Apr 6, 2012Estimated

Enrollment

10Estimated

Phase

Not provided

Conditions

Carotid Atherosclerosis

Interventions

PET-CT with CuATSM

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulty producing tracer

Expanded Access Info

Start Date

Oct 2012

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 21, 2009

First Submission Date that Met QC Criteria

Oct 21, 2009

First Posted Date

Oct 22, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 5, 2012

Last Update Posted Date

Apr 6, 2012Estimated

Name	Class
Guy's and St Thomas' NHS Foundation Trust	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients undergoing carotid endarterectomy			Other: PET-CT with CuATSM

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PET-CT with CuATSM	Other	PET-CT with CuATSM	Patients undergoing carotid endarterectomy

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients undergoing carotid endarterectomy

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Matt Waltham, MA PhD	King's College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St Thomas' Hospital		London		SE1 7EH	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D002340	Carotid Artery Diseases

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
GSTT Charity 251983
EudraCT 2009-011476-30