Imaging of Unstable Carotid Plaque in Patient Referred to... | NCT03353103

Studies
Imaging of Unstable Carotid Plaque in Patient Referred to Endarterectomy

NCT03353103

Sponsor

University Hospital, Caen

Status

Unknown status

Last Update Posted

Jan 13, 2020Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Carotid Artery Stenosis

Interventions

Sodium fluoride F-18 PET imaging

Countries

France

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

Jan 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2018Actual

Primary Completion Date

Jun 2020Estimated

Completion Date

Jun 2021Estimated

First Submitted Date

Apr 14, 2017

First Submission Date that Met QC Criteria

Nov 22, 2017

First Posted Date

Nov 27, 2017Actual

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

Jan 9, 2020

Last Update Posted Date

Jan 13, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study will assess unstable plaque imaging features by using high resolution MR imaging and Sodium Fluoride F-18 PET. This is a comparative study between symptomatic and asymptomatic patient referred to carotid endateriectomy, with reference to pathologic analysis of plaque components

Detailed Description

Not provided

Design Module

Study Type

Interventional

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
symptomatic	Active Comparator		Drug: Sodium fluoride F-18 PET imaging
asymptomatic	Active Comparator		Drug: Sodium fluoride F-18 PET imaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Sodium fluoride F-18 PET imaging	Drug	prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging	asymptomatic symptomatic

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
carotid F18-NaF uptake	do the symptomatic patients have a higher F18-NaF uptake compared to asymptomatic patients? at pre-operative examination	baseline

Secondary Outcomes

Measure	Description	Time Frame
comparaison of F18-NaF PET and Carotid MRI	comparaison between F18-NaF uptake and MR features of plaque instability at pre-operative examination	baseline
F18-NaF PET uptake	comparaison between F18-NaF uptake at pre-operative imaging

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age over 18 years old
Health care system affiliation
Referred to carotid endarterectomy
Symptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- TIA or minor stroke attack (RANKIN ≤ 3)
Asymptomatic patients:
- Carotid stenosis between 70 and 99% (NASCET criteria)
- No symptoms
Patient who has been informed of the study and has given his/her informed consent

Exclusion Criteria:

Contra indication to MRI
Renal failure (clearance < 30ml/mn)
Patient with active inflammatory disease
History of cancer
Pregnancy or lactation
Patient with carotid disease treated by fibrinolysis
Patient under guardianship, or unable to understand the purpose of the study

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lucie Cameliere, MD	Contact	+33231065161		cameliere-l@chu-caen.fr
Alain Manrique, MD PhD	Contact	+33231470287		manrique@cyceron.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Caen University Hospital	Recruiting	Caen			France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016893	Carotid Stenosis

Ancestor Terms

ID	Term
D002340	Carotid Artery Diseases
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided