Back to resultsComparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors (GLIROPA)
Primary Purpose
Brain Neoplasms, Adult Brain Tumor
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET imagery
Sponsored by
About this trial
This is an interventional diagnostic trial for Brain Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Suspected glial resectable tumor
- Free and informed consent
- Affiliated to French social security
Exclusion Criteria:
- Suspected high grade glioma
- Surgical emergency
- Pregnant or breastfeeding woman
- Patient deprived of their liberty or under guardianship
- Patient not able to follow study medical monitoring for geographical, social or psychological reasons
- Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery
Sites / Locations
- Centre Eugène Marquis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PET Arm
Arm Description
Outcomes
Primary Outcome Measures
PET pictures and MRI sequences comparison
Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03525080
Brief Title
Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors
Acronym
GLIROPA
Official Title
Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
June 12, 2018 (Actual)
Primary Completion Date
September 11, 2019 (Actual)
Study Completion Date
September 11, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Center Eugene Marquis
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery.
The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Neoplasms, Adult Brain Tumor
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PET Arm
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
PET imagery
Intervention Description
Every patients will have a PET imagery in addition to standard MRI
Primary Outcome Measure Information:
Title
PET pictures and MRI sequences comparison
Description
Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings
Time Frame
Imagings performed up to 29 days after inclusion (before brain surgery)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suspected glial resectable tumor
Free and informed consent
Affiliated to French social security
Exclusion Criteria:
Suspected high grade glioma
Surgical emergency
Pregnant or breastfeeding woman
Patient deprived of their liberty or under guardianship
Patient not able to follow study medical monitoring for geographical, social or psychological reasons
Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Florence LE JEUNE, Professor
Organizational Affiliation
Centre Eugène Marquis
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Eugène Marquis
City
Rennes
State/Province
Bretagne
ZIP/Postal Code
35042
Country
France
12. IPD Sharing Statement
Learn more about this trial
Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors
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