Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas (SPECIFY)

April 15, 2020 updated by: University Hospital, Montpellier

Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment

Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34295
        • Uhmontpellier

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gliomes de grade II initial
Other: Repeated Measurements of the relative regional cerebral blood volume
Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Collection of histological
Time Frame: 1 day
Collection of histological
1 day
Collection of radiological
Time Frame: 1 day
Collection of radiological
1 day
Collection of clinical varaibles
Time Frame: 1 day
Collection of clinical varaibles
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Nicolas MENJOT DE CHAMPFLEUR, MD, PhD, University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 30, 2019

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

April 10, 2020

First Submitted That Met QC Criteria

April 10, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

April 16, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF9647

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

NC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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