Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06113705

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

Led by Istituto Clinico Humanitas · Updated on 2025-01-31

75

Participants Needed

1

Research Sites

165 weeks

Total Duration

On this page

Sponsors

I

Istituto Clinico Humanitas

Lead Sponsor

M

Mediolanum Cardio Research

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients 18 years or older of any sex and race
  • Histologically confirmed IDH wild-type glioblastoma multiforme or clinical diagnosis consistent with IDH wild-type glioblastoma
  • Eligible for treatment with temozolomide and radiotherapy according to institutional guidelines
  • Willing and able to provide informed consent and participate in the trial
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Not eligible for treatment with temozolomide and radiotherapy
  • Contraindications to contrast-enhanced MRI such as pacemaker or gadolinium allergy
  • HIV positive
  • Presence of other systemic infectious or inflammatory diseases affecting the central nervous system (e.g., multiple sclerosis, lupus, Crohn's disease, rheumatoid arthritis)
  • Pregnant or breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

IRCCS Istituto Clinico Humanitas

Rozzano, Italy, 20089

Actively Recruiting

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Research Team

L

Letterio S Politi, MD

CONTACT

L

Luca A Cappellini, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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