Identifying glioblastoma pseudoprogression using imaging and biomarkers

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study aims to develop and validate imaging markers, including MRI and PET scans, along with plasma and cell biomarkers, to help differentiate between pseudoprogression and true tumor progression in glioblastoma patients. The study will create predictive models based on advanced imaging and biological markers, and establish an in vivo murine model of pseudoprogression using glioblastoma stem cells. Participants will undergo various assessments, including blood withdrawal and advanced imaging techniques, to support the study's objectives.

Why it matters

Who can join: the full rules

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. -

Where it's running

• IRCCS Istituto Clinico Humanitas
  Rozzano, Italy Recruiting

Study contacts

• Principal investigator: Letterio S Politi, MD — Humanitas Research Hospital IRCCS, Rozzano-Milan
• Study coordinator: Letterio S Politi, MD
• Email: letterio.politi@hunimed.eu
• Phone: +390282245644

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.