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

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Patients of both sex and any race age \>= 18.

• Histologically proven glioblastoma multiforme wild type for IDH1-2 mutation with MGMT promoter methylated or unmethylated OR subjects with medical history, clinical sign and symptoms and MRI findings highly consistent with the diagnosis of IDH wild type glioblastoma.

• Patient eligible to undergo treatment with TMZ and RT (Stupp protocol or hypofractionated protocol as per Institutional Multidisciplinary Brain Tumor Board's decision)

• Willingness and ability to sign the informed consent and participate to the trial.

Locations
Other Locations
Italy
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Contact Information
Primary
Letterio S Politi, MD
letterio.politi@hunimed.eu
+390282245644
Backup
Luca A Cappellini, MD
luca.cappellini@humanitas.it
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 75
Treatments
Experimental: Experimental Arm
Multidisciplinary and innovative approach based on plasma markers of inflammation (cytokines, circulating RNA, and extracellular microvesicles), and multimodal imaging using 18F-GE-180 positron emission tomography (PET) and advanced MRI techniques,
Sponsors
Leads: Istituto Clinico Humanitas
Collaborators: Mediolanum Cardio Research

This content was sourced from clinicaltrials.gov

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