GliomaIMOTEPNCT02022800
Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET)
A study testing PET 18FDOPA in people with Glioma and Cerebral Metastases, run by Centre Antoine Lacassagne at 1 site in France.
Trial summary
In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glioma, Cerebral Metastases
- What is being tested?
- PET 18FDOPA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Jun 2016
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a historically proven high level of glimoa or of cerebral metastases
- Patients who have their files presented in a neurological oncologic CMM in one of the following situations:
- Diagnosis doubt between radionecrosis and tumor progression
- Evaluation at the end of the radio and chemotherapy period
- Evaluation under anti-angiogenic 18 years or older Patients who have been informed and have signed the consent form indicated in the study Patients with insurance coverage
Who cannot join
- Patients for whom having an MRI or a PET 18F-FDOPA would be contraindicated in light of any co-morbidities or allergies that it reveals
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET) in a Multidisciplinary Meeting Therapeutic Proposal When Caring for Patients Diagnosed Primary or Secondary Cerebral Tumors
In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at least 3 months in order to clarify the situation, with a potential delay in diagnosis and therefore therapeutic care. The contribution of cerebral molecular imagery could allow for new additional information to be brought in or to increase the confidence index in the diagnosis in order to comfort the therapeutic collective attitude proposed in the multidisciplinary meeting (MM).
3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid, Position Emission Tomography (PET), allows for the studying in vivo of the proteic transmembrane transport in gliomatous tissue; active transport happens through a sodic-independent canal, increased in malicious transformations, and in which kinetics can give an indication regarding the development of the primary tumor.
Read more
In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is independent of the state of integrity of the BBB and whose only function is metabolic tissue activity. This method of imagery thus appears as a promising contribution to conventional imagery.
Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose), similar to the largely used glucose in oncologic molecular imagery, exploration of harmful glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a level of reference. The best performances in terms of positive and negative predictive value were defined in the literature with a tumor/striatum threshold of 1.
According to the latest and current European recommendations, turning to PET when caring for high-level gliomas patients can be proposed in the evaluation of therapeutic responses. However, very few studies have evaluated the in-practice current clinical contributions of PET and put it into perspective with classic clinical radiological data.
Read the detailed description
The primary hypothesis rests on the fact that 18F-FDOPA PET imagery can modify decisions regarding the treatment of patients during oncologic neurological MDM. It's a matter of measuring the frequency in attitude and situations changes in which these changes most often occur.
Secondly, the study will have the objective, during patient follow-up, to evaluate the pertinence of these changes in decisions, as well as the usage of PET in relation to clinical situations:
- The differential diagnosis between radionecrosis or pseudo-progression and recurrence before newly appeared contrast zones in patients diagnosed a high glioma level or metastasis and treated by radiotherapy; either with or without chemotherapy.
- The evaluation at the end of treatment with introductory level temozolomide (TMZ) (6th cycle) after adjuvant radio-chemotherapy of a high-level primary cerebral tumor.
- The evaluation of the response under anti-angeogenic treatment
The expected benefit of this study is an improvement in the patient's care. Indeed, the additional information provided by Position Emission Tomography (PET) could allow for healthcare professionals to more precociously test for recurrence and thus diminish the delay in therapeutic care. Conversely, the PET could allow for healthcare professionals to avoid over-treatment of patients for whom the MRI would wrongly indicate a recurrence. Furthermore, imagery by PET should bring a new level of additional information allowing for an increase in the confidence index when being diagnosed, thus comforting the collective therapeutic attitude proposed in the MM.
- Conditions
- Glioma, Cerebral Metastases
- Being tested
- PET 18FDOPA
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET 18FDOPAOther
contribution of PET 18FDOPAimagery in high level glioma diagnosis
| Study group | Role | What they receive |
|---|---|---|
| PET 18FDOPA | Other | PET 18FDOPA Receives: Other: PET 18FDOPA |
What is being measured
The primary outcome is the main question the study is designed to answer.
confidence level in the therapeutic decision regarding the results from PET 18F-FDOPA imagery, in comparison with MRI alone.
Measured: 1 year up to 2 years
Secondary outcomes (2)
Validation of the decision taken with knowledge of the results from the PET 18F-FDOPA for post-operated patients
Measured: 1 year up to 2 years
evaluation of PET 18F-FDOPA contribution according to clinical situations
Measured: 1 year up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for GliomaStudies 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
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jacques DARCOURT, phd, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02022800
- Sponsor's protocol ID
- 2012/56
- Acronym
- IMOTEP
- Status last verified
- Apr 2026
- First submitted
- 19 Nov 2013
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Humbert O, Bourg V, Mondot L, Gal J, Bondiau PY, Fontaine D, Saada-Bouzid E, Paquet M, Chardin D, Almairac F, Vandenbos F, Darcourt J. 18F-DOPA PET/CT in brain tumors: impact on multidisciplinary brain tumor board decisions. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):558-568. doi: 10.1007/s00259-018-4240-8. Epub 2019 Jan 5.
PubMed 30612162
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET) in a Multidisciplinary Meeting Therapeutic Proposal When Caring for Patients Diagnosed Primary or Secondary Cerebral Tumors
- ClinicalTrials.gov ID
- NCT02022800
- Acronym / sponsor ID
- IMOTEP / 2012/56
- Conditions
- Glioma, Cerebral Metastases
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Antoine LacassagneUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
In standard care for patients diagnosed with a primary or secondary (metastasis) cerebral tumor, there is currently complex clinical situations in which the clinic and Magnetic Resonance Imagery (MRI) do not allow for the medical team to arrive at a conclusive diagnosis. The therapeutic proposition requires then a delay in additional follow-up of at least 3 months in order to clarify the situation, with a potential delay in diagnosis and therefore therapeutic care. The contribution of cerebral molecular imagery could allow for new additional information to be brought in or to increase the confidence index in the diagnosis in order to comfort the therapeutic collective attitude proposed in the multidisciplinary meeting (MM).
3.4-dihydroxy-6-18F-fluoro-L-phenylalanine (18F-FD0PA), dopamine precursor amino-acid, Position Emission Tomography (PET), allows for the studying in vivo of the proteic transmembrane transport in gliomatous tissue; active transport happens through a sodic-independent canal, increased in malicious transformations, and in which kinetics can give an indication regarding the development of the primary tumor.
In MRIs, tumor tissue growth after injecting the contrast product translates to a rupture in the Blood-Brain Barrier (BBB), while tumor extraction from the radiopharmaceutical is independent of the state of integrity of the BBB and whose only function is metabolic tissue activity. This method of imagery thus appears as a promising contribution to conventional imagery.
Furthermore, different to 18F-FDG (18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose), similar to the largely used glucose in oncologic molecular imagery, exploration of harmful glioma in 18F-FDOPA, is not compromised by background noise activity, and is almost useless in a healthy cerebral cortex, with the exception of striatal physiological fixation used as a level of reference. The best performances in terms of positive and negative predictive value were defined in the literature with a tumor/striatum threshold of 1.
According to the latest and current European recommendations, turning to PET when caring for high-level gliomas patients can be proposed in the evaluation of therapeutic responses. However, very few studies have evaluated the in-practice current clinical contributions of PET and put it into perspective with classic clinical radiological data.
Detailed description
The primary hypothesis rests on the fact that 18F-FDOPA PET imagery can modify decisions regarding the treatment of patients during oncologic neurological MDM. It's a matter of measuring the frequency in attitude and situations changes in which these changes most often occur.
Secondly, the study will have the objective, during patient follow-up, to evaluate the pertinence of these changes in decisions, as well as the usage of PET in relation to clinical situations:
- The differential diagnosis between radionecrosis or pseudo-progression and recurrence before newly appeared contrast zones in patients diagnosed a high glioma level or metastasis and treated by radiotherapy; either with or without chemotherapy.
- The evaluation at the end of treatment with introductory level temozolomide (TMZ) (6th cycle) after adjuvant radio-chemotherapy of a high-level primary cerebral tumor.
- The evaluation of the response under anti-angeogenic treatment
The expected benefit of this study is an improvement in the patient's care. Indeed, the additional information provided by Position Emission Tomography (PET) could allow for healthcare professionals to more precociously test for recurrence and thus diminish the delay in therapeutic care. Conversely, the PET could allow for healthcare professionals to avoid over-treatment of patients for whom the MRI would wrongly indicate a recurrence. Furthermore, imagery by PET should bring a new level of additional information allowing for an increase in the confidence index when being diagnosed, thus comforting the collective therapeutic attitude proposed in the MM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET 18FDOPA | Other | Other: PET 18FDOPAPET 18FDOPA |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a historically proven high level of glimoa or of cerebral metastases
- Patients who have their files presented in a neurological oncologic CMM in one of the following situations:
- Diagnosis doubt between radionecrosis and tumor progression
- Evaluation at the end of the radio and chemotherapy period
- Evaluation under anti-angiogenic 18 years or older Patients who have been informed and have signed the consent form indicated in the study Patients with insurance coverage
Key exclusion criteria (1 listed)
- Patients for whom having an MRI or a PET 18F-FDOPA would be contraindicated in light of any co-morbidities or allergies that it reveals
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 18FDOPAcontribution of PET 18FDOPAimagery in high level glioma diagnosis | Other | PET 18FDOPA |
Primary outcome
confidence level in the therapeutic decision regarding the results from PET 18F-FDOPA imagery, in comparison with MRI alone.
Time frame: 1 year up to 2 years
2 secondary outcomes
Validation of the decision taken with knowledge of the results from the PET 18F-FDOPA for post-operated patients
Time frame: 1 year up to 2 years
evaluation of PET 18F-FDOPA contribution according to clinical situations
Time frame: 1 year up to 2 years
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 23 Apr 2026.
- Results publication: PubMed 30612162Humbert O, Bourg V, Mondot L, Gal J, Bondiau PY, Fontaine D, Saada-Bouzid E, Paquet M, Chardin D, Almairac F, Vandenbos F, Darcourt J. 18F-DOPA PET/CT in brain tumors: impact on multidisciplinary brain tumor board decisions. Eur J Nucl Med Mol Imaging. 2019 Mar;46(3):558-568. doi: 10.1007/s00259-018-4240-8. Epub 2019 Jan 5.
- Related InfoLink provided by the sponsor.
Related trials for Glioma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
RecruitingPhase 1/2
000860: A Phase I/II Study of Zotiraciclib for Recurrent Malignant Gliomas With Isocitrate Dehydrogenase 1 or 2 (IDH1 or IDH2) Mutations
Brain Tumor, Cancer
Active, not recruitingPhase 2
Ensartinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With ALK or ROS1 Genomic Alterations (A Pediatric MATCH Treatment Trial)
Advanced Malignant Solid Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 2
Illuminate: A Clinical Study Evaluating CAR T Immune Cell Therapy (BCB-276) for Patients With Diffuse Intrinsic Pontine Glioma (DIPG).
Diffuse Intrinsic Pontine Glioma, DIPG
Not yet recruiting
GLAD-KE GLioma Biomarker and Safety Assessment During Dietary Ketone Elevation Subtitle: A Surgical Biomarker Discovery Study of Ketogenic Therapy in Recurrent Glioma
Recurrent Glioma (Glioblastoma Multiforme)
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.
Jacques DARCOURT, phd principal investigator
Centre Antoine Lacassagne
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 18FDOPA in people with Glioma and Cerebral Metastases, run by Centre Antoine Lacassagne 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 5 inclusion and 1 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 23 Apr 2026. 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?
confidence level in the therapeutic decision regarding the results from PET 18F-FDOPA imagery, in comparison with MRI alone. (time frame: 1 year up to 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02022800, which also lists 1 linked publication.
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 23 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.