NCT06113705

Brief 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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Nov 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Nov 2023Dec 2026

First Submitted

Initial submission to the registry

October 27, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

November 1, 2023

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 31, 2025

Status Verified

January 1, 2025

Enrollment Period

3.2 years

First QC Date

October 27, 2023

Last Update Submit

January 29, 2025

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Predictive models of pseudoprogression

    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)

    From baseline assessment to the last visit of the patient as per protocol

Secondary Outcomes (1)

  • Glioblastoma Stem Cells (GSCs) isolation and in vitro model

    starting from the day of the first surgery

Other Outcomes (1)

  • Glioblastoma and Hematopoietic Stem Cells isolation and in vivo model

    Starting from the day of the first surgery

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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,

Diagnostic Test: 18F-GE-180 PETDiagnostic Test: Advanced MRIOther: Collection of hematopoietic stem cellsOther: Blood withdrawalOther: Collection of Cancer Stem Cells

Interventions

18F-GE-180 PETDIAGNOSTIC_TEST

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

Experimental Arm
Advanced MRIDIAGNOSTIC_TEST

MRI examination using advanced sequences to characterize tumor microstructure and function

Experimental Arm
Collection of hematopoietic stem cellsOTHER

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

Experimental Arm
Blood withdrawalOTHER

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

Experimental Arm
Collection of Cancer Stem CellsOTHER

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

Experimental Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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. -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Letterio S Politi, MD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Letterio S Politi, MD

CONTACT

+390282245644letterio.politi@hunimed.eu

Luca A Cappellini, MD

CONTACT

luca.cappellini@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Administrator Manager

Study Record Dates

First Submitted

October 27, 2023

First Posted

November 2, 2023

Study Start

November 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 31, 2025

Record last verified: 2025-01

Locations

IT(1)