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

Recruiting now · Not applicable

Conditions studied: Glioblastoma

In brief

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

Key facts

Study ID

NCT06113705

Run by

Istituto Clinico Humanitas

People needed

75

Starts

2023-11-01

Expected to finish

2026-12-31

Last updated by the study team

2025-01-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patient age <18.
• Patient not eligible to undergo treatment with TMZ and RT (Stupp protocol or hypofractionated protocol as per Institutional Multidisciplinary Brain Tumor Board's decision).
• Patient presenting contraindication to undergo contrast-enhanced MRI (pacemaker or allergy to gadolinium).
• Patient HIV1-2 positive.
• Patient affected by other systemic infective or inflammatory diseases or involving the central nervous system (multiple sclerosis, lupus, Chron, rheumatoid arthritis).
• Patients that are pregnant or breast-feeding. -

Where it is running

• IRCCS Istituto Clinico Humanitas — Rozzano, Italy (enrolling)

Full record on ClinicalTrials.gov

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