NCT06113705Recruiting
Imaging and Biological Markers for Prediction and Identification of Glioblastoma Pseudoprogression: a Prospective Study.
Source: ClinicalTrials.gov · Last updated 31 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 75 (estimated)
- First submitted
- 27 Oct 2023
- Start date
- 1 Nov 2023
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Istituto Clinico Humanitas
- Diseases
- Glioblastoma
- NCT number
- NCT06113705
What you commit to
- Study type: Interventional
- Planned participants: 75
- From 1 Nov 2023 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patient not eligible to undergo treatment with TMZ and RT (Stupp protocol or hypofractionated protocol as per Institutional Multidisciplinary Brain Tumor Board's decision).
Other illness
- Patient presenting contraindication to undergo contrast-enhanced MRI (pacemaker or allergy to gadolinium).
- Patient affected by other systemic infective or inflammatory diseases or involving the central nervous system (multiple sclerosis, lupus, Chron, rheumatoid arthritis).
Age
- Patient age \<18.
Other
- Patient HIV1-2 positive.
- Patients that are pregnant or breast-feeding. -
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IRCCS Istituto Clinico Humanitas Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.