- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04346472
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
-
-
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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
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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
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
- Glioma
- Magnetic Resonance Imaging
- Disease Progression
- Contrast Media
- Magnetic Resonance Angiography
- Image Processing, Computer-Assisted
- Blood Volume
- Neovascularization, Pathologic
- Supratentorial Neoplasms
- Gadolinium DTPA
- Diffuse low grade glioma
- Relative regional cerebral blood volume ( rRCBV)
- Early prognosis of anaplasic transformation
- Diffuse low grade glioma anaplasic transformation
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.