RecruitingNot ApplicableNCT06113705

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


Sponsor

Istituto Clinico Humanitas

Enrollment

75 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study aims to find better ways to tell the difference between true cancer growth and "pseudoprogression" — when a brain tumor appears to grow on MRI scans after treatment but is actually just inflammation healing. Researchers will use advanced imaging and biological markers in patients with glioblastoma, an aggressive brain cancer. **You may be eligible if:** - You are 18 or older - You have a confirmed diagnosis of glioblastoma (a type of brain cancer) without IDH mutation - Your cancer is eligible for standard treatment with chemotherapy (temozolomide) and radiation - You are about to start or are currently on this standard treatment **You may NOT be eligible if:** - You have a different type of brain tumor - You are not able to undergo radiation and chemotherapy - You cannot provide informed consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST18F-GE-180 PET

PET examination of glioblastoma using 18F-GE-180 PET radio-metabolic marker

DIAGNOSTIC_TESTAdvanced MRI

MRI examination using advanced sequences to characterize tumor microstructure and function

OTHERCollection of hematopoietic stem cells

Hematopoietic stem cells will be collected by the aspiration of bone marrow during the surgical intervention for tumor resection

OTHERBlood withdrawal

blood withdrawal for evaluation of plasma biomarkers of inflammation, circulating microvesicles, and RNA

OTHERCollection of Cancer Stem Cells

Glioblastoma stem cells (GSCs) will be isolated from the tumor


Locations(1)

IRCCS Istituto Clinico Humanitas

Rozzano, Italy

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NCT06113705


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