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

NCT06113705 · tracked via the Priya Life Science Italy tracker

Sponsor

Istituto Clinico Humanitas

Phase

Not applicable

Started

2023-11-01

Last updated

2025-01-31

Condition(s) studied

Glioblastoma

Investigational drug(s) / intervention(s)

18F-GE-180 PETAdvanced MRICollection of hematopoietic stem cellsBlood withdrawalCollection of Cancer Stem Cells

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

Advanced MRI: MRI examination using advanced sequences to characterize tumor microstructure and function

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

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

Collection of Cancer Stem Cells: Glioblastoma stem cells (GSCs) will be isolated from the tumor

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

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: 1. Patients of both sex and any race age \>= 18. 2. 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. 3. Patient eligible to undergo treatment with TMZ and RT (Stupp protocol or hypofractionated protocol as per Institutional Multidisciplinary Brain Tumor Board's decision) 4. Willingness and ability to sign the informed consent and participate to the trial. Exclusion Criteria: 1. Patient age \<18. 2. Patient not eligible to undergo treatment with TMZ and RT (Stupp protocol or hypofractionated protocol as per Institutional Multidisciplinary Brain Tumor Board's decision). 3. Patient presenting contraindication to undergo contrast-enhanced MRI (pacemaker or allergy to gadolinium). 4. Patient HIV1-2 positive. 5. Patient affected by other systemic infective or inflammatory diseases or involving the central nervous system (multiple sclerosis, lupus, Chron, rheumatoid arthritis). 6. Patients that are pregnant or breast-feeding. -

Primary outcome measure(s)

Predictive models of pseudoprogression — From baseline assessment to the last visit of the patient as per protocol
predictive models (evaluation of specificity and sensitivity) 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 GBM who underwent therapeutical protocol as per treating physicians' indications (Stupp or hypofractionated RT)

Trial sites (1)

Facility	City	Region	Status
IRCCS Istituto Clinico Humanitas	Rozzano	Italy	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06113705 on ClinicalTrials.gov ↗ ← All trials in Italy