FET-PET and Multiparametric MRI for High-grade Glioma Patients Undergoing Radiotherapy (IMAGG)
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|ClinicalTrials.gov Identifier: NCT03370926|
Recruitment Status : Recruiting
First Posted : December 13, 2017
Last Update Posted : December 13, 2017
Glioblastoma is the most common malignant brain tumor in adults. The primary treatment consists of maximal tumor removal followed by radiotherapy (RT) with concomitant and adjuvant temozolomide. Tumor recurrence after chemoradiotherapy has previously been shown to be predominantly within or at the margin of the irradiated volume, but distant failure are not rare, especially in patients with MGMT methylation.Traditionally, RT has been planned based on on planning CT with co-registered postoperative MRI, with the addition of a clinical target volume margin of 2-3 cm to account for infiltrative odema.
To better characterize the disease, more specific physiological and/or metabolical markers of tumor cells, vascularization and hypoxia measured on multiparametric MRI as perfusion, diffusion and spectroscopy alongside with PET tracer like Fluoroéthyl-L-tyrosine ([18F]-FET) are now available and suggest that aggressive areas, like uptake of PET tracer and vascularity are present outside areas of contrast enhancement usually irradiated. These informations could be incorporated to optimize the treatment of radiotherapy.
|Condition or disease|
|Glioblastoma Multiforme Anaplastic Astrocytoma Radiotherapy|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||(18F)-Fluoroethyl-L-tyrosine Positron Emission Tomography and Multiparametric MRI for the Delination of Target Volumes in High-grade Glioma Patients Undergoing Radiotherapy|
|Actual Study Start Date :||October 31, 2016|
|Estimated Primary Completion Date :||October 31, 2019|
|Estimated Study Completion Date :||October 31, 2019|
- Target volumes contoured on standard MRI and planning CT, FET-PET and multiparametric MRI images [ Time Frame: 12 months ]Increase in at least 10% of irradiation target volumes compared to the result of the MRI+scanner reference technique.
- Treatment failure pattern in respect to the target volume based on standard MRI, multiparametric MRI and FET-PET. [ Time Frame: 12 months ]Irradiation target volumes associated with standard MRI
- Sites of failures with composite and standard MRI based RT planning [ Time Frame: 12 months ]Irradiation target volumes associated with standard MRI based RT planning
- Progression-free Survival [ Time Frame: 12 months ]
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): NCT03370926
|Contact: Ulrick SCHICKfirstname.lastname@example.org|
|CHRU de Brest||Recruiting|
|Brest, France, 29609|
|Contact: Ulrike SCHICK email@example.com|