Identifying glioblastoma pseudoprogression using imaging and biomarkers

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

This study is testing new imaging and blood tests to help doctors tell the difference between false signs of tumor growth and real tumor progression in patients with glioblastoma.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Istituto Clinico Humanitas (Academic / other)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Rozzano)
• Trial ID: NCT06113705 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed glioblastoma multiforme who are eligible for treatment with temozolomide and radiotherapy.

Not a fit: Patients under 18, those not eligible for temozolomide and radiotherapy, or those with contraindications for MRI will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate assessments of glioblastoma progression, potentially improving treatment decisions and patient outcomes.

How similar studies have performed: While the differentiation of pseudoprogression from true progression is a known challenge, this specific approach using advanced imaging and biomarkers is novel and has not been extensively tested in prior studies.

Eligibility criteria

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 this trial is running

Rozzano

• 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

Conditions Glioblastoma