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

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

Conditions

• Glioblastoma

Interventions

DIAGNOSTIC_TEST

18F-GE-180 PET

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

DIAGNOSTIC_TEST

Advanced MRI

MRI examination using advanced sequences to characterize tumor microstructure and function

OTHER

Collection of hematopoietic stem cells

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

OTHER

Blood withdrawal

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

OTHER

Collection of Cancer Stem Cells

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

Sponsors & Collaborators

• Mediolanum Cardio Research

  collaborator OTHER

• Istituto Clinico Humanitas

  lead OTHER

Principal Investigators

• Letterio S Politi, MD · IRCCS Istituto Clinico Humanitas

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-11-01

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• Italy

Study Locations