Status:
RECRUITING
Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study.
Lead Sponsor:
Istituto Clinico Humanitas
Collaborating Sponsors:
Mediolanum Cardio Research
Conditions:
Glioblastoma
Eligibility:
All Genders
18+ years
Phase:
NA
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 differe...
Detailed Description
Rationale Glioblastoma (GBM) is the most common malignant primary tumor of the central nervous system characterized by an extremely severe prognosis with a median survival of 14-16 months from diagno...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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. -
Key Trial Info
Start Date :
November 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT06113705
Start Date
November 1 2023
End Date
December 31 2026
Last Update
January 31 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
IRCCS Istituto Clinico Humanitas
Rozzano, Italy, 20089