Prospective Study on Oncologic Cerebral Imagery Contribution by 18F-FDOPA Position Emission Tomography (PET) (IMOTEP)
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|ClinicalTrials.gov Identifier: NCT02022800|
Recruitment Status : Completed
First Posted : December 30, 2013
Last Update Posted : July 26, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Glioma Cerebral Metastases||Other: PET 18FDOPA||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||85 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||June 2016|
Other: PET 18FDOPA
contribution of PET 18FDOPAimagery in high level glioma diagnosis
- 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 ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02022800
|Centre Antoine Lacassagne|
|Nice, France, 06189|
|Principal Investigator:||Jacques DARCOURT, phd||Centre Antoine Lacassagne|