NCT03525080

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 15, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

June 12, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 11, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 11, 2019

Completed
Last Updated

January 27, 2020

Status Verified

January 1, 2020

Enrollment Period

1.2 years

First QC Date

May 2, 2018

Last Update Submit

January 23, 2020

Conditions

Brain NeoplasmsAdult Brain Tumor

Outcome Measures

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

    Imagings performed up to 29 days after inclusion (before brain surgery)

Study Arms (1)

PET Arm

EXPERIMENTAL
Diagnostic Test: PET imagery

Interventions

PET imageryDIAGNOSTIC_TEST

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

PET Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Eugène Marquis

Rennes, Brittany Region, 35042, France

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Florence LE JEUNE, Professor

    Centre Eugène Marquis

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2018

First Posted

May 15, 2018

Study Start

June 12, 2018

Primary Completion

September 11, 2019

Study Completion

September 11, 2019

Last Updated

January 27, 2020

Record last verified: 2020-01

Locations

FR(1)