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CompletedNCT03525080GLIROPAUpdated Jan 27, 2020

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

An interventional study of PET imagery in Brain Neoplasms and Adult Brain Tumor, sponsored by Center Eugene Marquis. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-27.

Sponsored by Center Eugene Marquis · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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)

02

Conditions studied

  • Brain Neoplasms
  • Adult Brain Tumor

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03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 16 is below the median of 40 across 1,458 interventional studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

Center Eugene Marquis is the lead sponsor of 32 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Suspected glial resectable tumor
  • Free and informed consent
  • Affiliated to French social security

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    PET Arm

    Diagnostic Test: PET imagery

Interventions

  • Diagnostic testPET imagery

    Every patients will have a PET imagery in addition to standard MRI

06

What researchers measure

Primary outcomes

  1. PET pictures and MRI sequences comparison

    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)

07

Study locations

1 site
  • Centre Eugène Marquis
    Rennes, Bretagne 35042, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03525080
Lead sponsor
Center Eugene Marquis
Responsible party
Sponsor
First posted
May 15, 2018
Start date
Jun 12, 2018
Primary completion
Sep 11, 2019
Completion
Sep 11, 2019
Last update
Jan 27, 2020

Study contacts

Florence LE JEUNE, Professor
principal investigator · Centre Eugène Marquis

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.

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