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NCT03525080 Clinical 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

Brain Neoplasms Clinical Trial

— GLIROPA  

Official title:
Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03525080
Other study ID # 2017-4-52-010
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 12, 2018
Est. completion date September 11, 2019

Study information
Verified date January 2020
Source Center Eugene Marquis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date September 11, 2019
Est. primary completion date September 11, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• PET imagery
Every patients will have a PET imagery in addition to standard MRI

Locations
Country Name City State
France Centre Eugène Marquis Rennes Bretagne

Sponsors (1)
Lead Sponsor Collaborator
Center Eugene Marquis

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary PET pictures and MRI sequences comparison Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings Imagings performed up to 29 days after inclusion (before brain surgery)
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