Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study. - Trial NCT06113705

Timeline & Enrollment

Primary Outcome

Predictive models of pseudoprogression

Summary

The goal of this interventional study is the development and validation of imaging markers,
 MRI and PET, plasma biomarkers, and/or cell markers that could support clinicians and
 researchers in differentiating pseudoprogression from true tumor progression in routine
 clinical activities and clinical trials in patients affected by glioblastoma.
 
 The endpoints of the study are:
 
 - the elaboration of predictive models using imaging advanced biomarkers, PET and MRI,
 biological serum markers, and cancer cell derived makers to differentiate tumor
 pseudoprogression or real progression in patients affected by glioblastoma who underwent
 therapeutical protocol as per treating physicians' indications (Stupp or
 hypofractionated RT)
 
 - to establish an in vivo murine model of pseudoprogression by orthotopic transplantation
 of glioblastoma stem cells derived from thirty-five patient subjected to subsequent
 treatment with irradiation and temozolomide administration.
 
 Participants will undergo:
 
 - baseline MRI and 18F-GE-180 PET imaging, and blood withdrawal
 
 - surgery
 
 - collection of glioblastoma stem cells (and hematopoietic stem cells from a sub-group of
 subjects)
 
 - standard treatment with radiotherapy and chemotherapy
 
 - MRI every 3 months
 
 - PET and blood withdrawal in case of MRI evidence of either suspected tumor progression
 or pseudoprogression
 
 - second surgery OR stereotactic biopsy OR clinico-radiological follow-up as for standard
 of care according to the Institutional Multidisciplinary Brain Tumor Board

ICD-10 Classifications