Correlation Between PET and Advanced MRI in Multiple Scle... | NCT02869360

Studies
Correlation Between PET and Advanced MRI in Multiple Sclerosis

NCT02869360

Sponsor

University of British Columbia

Status

Completed

Last Update Posted

Oct 3, 2019Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Not provided

Countries

Canada

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

Oct 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2016

Primary Completion Date

Oct 2, 2019Actual

Completion Date

Oct 2, 2019Actual

First Submitted Date

Aug 12, 2016

First Submission Date that Met QC Criteria

Aug 12, 2016

First Posted Date

Aug 16, 2016Estimated

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

Oct 2, 2019

Last Update Posted Date

Oct 3, 2019Actual

Name	Class
Teva Pharmaceuticals USA	INDUSTRY

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

Traditional Magnetic Resonance Imaging (MRI) in Multiple Sclerosis (MS) has enabled clinicians to measure disease activity but there are inherent limitations. Clinical/radiographic dissociation can be seen in some patients and the abnormalities are not specific.

This pilot study is an opportunity to determine the relationship between quantitative advanced MRI measures and OCT with PET measurements of microglial activation and myelin health.

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

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

14Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multiple Sclerosis (MS) patients		4 Secondary Progressive MS patients on no disease modifying therapy 4 Primary Progressive MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on no disease modifying therapy 4 Relapsing-Remitting MS patients on Glatiramer Acetate 40 mg three times a week
Healthy Controls		4 Healthy volunteers aged between 18-60 years of age

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Whole Brain PBR28 binding		Baseline

Secondary Outcomes

Measure	Description	Time Frame
Lesional PiB binding		Baseline
Myelin Water Imaging		Baseline
MR Spectroscopy (Total NAA, NAA/Cr, mI)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed with Multiple Sclerosis according to the 2011 McDonald criteria.
Aged 18 to 60
High or mixed affinity binder to rs6971 TSPO polymorphism

Exclusion Criteria:

Pregnant or breastfeeding
Suffering from an unstable medical condition
Have a neurological or ocular disorder other than MS
Any contra-indications to MRI

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

4 untreated RRMS, 4 untreated SPMS, 4 untreated PPMS patients, 4 healthy controls and 4 GA 40mg TIW

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
MS Clinical Trials Group - UBC		Vancouver	British Columbia	V6T 1Z3	Canada

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided