Brain NeoplasmsGLIROPANCT03525080
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
A study testing PET imagery in people with Brain Neoplasms and Adult Brain Tumor, run by Center Eugene Marquis at 1 site in France.
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Brain Neoplasms, Adult Brain Tumor
- What is being tested?
- PET imagery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2018to 11 Sep 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected glial resectable tumor
- Free and informed consent
- Affiliated to French social security
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors
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)
- Conditions
- Brain Neoplasms, Adult Brain Tumor
- Being tested
- PET imagery
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET imageryDiagnostic test
Every patients will have a PET imagery in addition to standard MRI
| Study group | Role | What they receive |
|---|---|---|
| PET Arm | Experimental | Not described Receives: Diagnostic Test: PET imagery |
What is being measured
The primary outcome is the main question the study is designed to answer.
PET pictures and MRI sequences comparison
Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings
Measured: Imagings performed up to 29 days after inclusion (before brain surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2018
- Study start12 Jun 2018
- Primary completion11 Sep 2019
- Study completion11 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence LE JEUNE, Professor, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03525080
- Sponsor's protocol ID
- 2017-4-52-010
- Acronym
- GLIROPA
- Status last verified
- Jan 2020
- First submitted
- 2 May 2018
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors
- ClinicalTrials.gov ID
- NCT03525080
- Acronym / sponsor ID
- GLIROPA / 2017-4-52-010
- Conditions
- Brain Neoplasms, Adult Brain Tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- 12 Jun 2018 (actual)
- Primary completion
- 11 Sep 2019 (actual)
- Study completion
- 11 Sep 2019 (actual)
- First posted
- 15 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET Arm | Experimental | Diagnostic Test: PET imagery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Suspected glial resectable tumor
- Free and informed consent
- Affiliated to French social security
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET imageryEvery patients will have a PET imagery in addition to standard MRI | Diagnostic test | PET Arm |
Primary outcome
PET pictures and MRI sequences comparison
Time frame: Imagings performed up to 29 days after inclusion (before brain surgery)
Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florence LE JEUNE, Professor principal investigator
Centre Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET imagery in people with Brain Neoplasms and Adult Brain Tumor, run by Center Eugene Marquis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PET pictures and MRI sequences comparison (time frame: Imagings performed up to 29 days after inclusion (before brain surgery)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2020.