Longitudinal MRI Assessment in Patients With Diffuse Low-... | NCT04346472

Studies
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas

NCT04346472

Sponsor

University Hospital, Montpellier

Status

Completed

Last Update Posted

Apr 16, 2020Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Low-grade Glioma

Interventions

Repeated Measurements of the relative regional cerebral blood volume

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

Apr 2020

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

Mar 1, 2016Actual

Primary Completion Date

Dec 30, 2019Actual

Completion Date

Jan 30, 2020Actual

First Submitted Date

Apr 10, 2020

First Submission Date that Met QC Criteria

Apr 10, 2020

First Posted Date

Apr 15, 2020Actual

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 15, 2020

Last Update Posted Date

Apr 16, 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

Not provided

FDAAA801 Violation

Not provided

Conditions Module

Conditions

Low-grade Glioma

Keywords

Glioma
Magnetic Resonance Imaging
Magnetic Resonance Angiography
Disease Progression
Supratentorial Neoplasms
Blood Volume
Contrast Media
Gadolinium DTPA
Image Processing, Computer-Assisted
Neovascularization, Pathologic
Diffuse low grade glioma
Relative regional cerebral blood volume ( rRCBV)
Early prognosis of anaplasic transformation
Diffuse low grade glioma anaplasic transformation

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

200Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gliomes de grade II initial		Gliomes de grade II initial	Other: Repeated Measurements of the relative regional cerebral blood volume

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Repeated Measurements of the relative regional cerebral blood volume	Other	Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Longitudinal variation of the relative regional cerebral blood volume	Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed	1 day

Secondary Outcomes

Measure	Description	Time Frame
Collection of histological	Collection of histological	1 day
Collection of radiological	Collection of radiological	1 day

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

Initial WHO grade II
At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging

Exclusion criteria:

-Major protected person ( trusteeship, curatorship, justice safeguard)

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

Patients with diffuse low-grade glioma (WHO grade II)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Nicolas MENJOT DE CHAMPFLEUR, MD, PhD	University Hospital, Montpellier	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Uhmontpellier		Montpellier		34295	France

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D005910	Glioma
D018450	Disease Progression
D015173	Supratentorial Neoplasms
D009389	Neovascularization, Pathologic

Ancestor Terms

ID	Term
D018302	Neoplasms, Neuroepithelial
D017599	Neuroectodermal Tumors
D009373	Neoplasms, Germ Cell and Embryonal
D009370	Neoplasms by Histologic Type

Browse Leaves

Not provided

Browse Branches

Not provided