Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.

NCT ID: NCT07119294

Last Updated: 2025-08-13

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-31
• Study Completion Date: 2028-06-30

Brief Summary

Glioblastoma is a highly aggressive and malignant form of brain cancer that arises from the glial cells of the brain. It is the most common and deadliest type of primary brain tumor in adults, with a very poor prognosis and a low survival rate. Glioblastoma is characterized by rapid and uncontrolled growth, infiltrative invasion into surrounding brain tissue, and resistance to standard treatments. Therefore, new therapeutic strategies are highly needed. A subpopulation of fibroblasts called "cancer-associated fibroblasts" (CAFs) is know to be a key constituent of tumor stroma in several non-CNS tumors (e.g., breast, colon, lung,ovarian, or pancreatic cancers) . These CAFs express a specific protein called "fibroblast activation protein" (FAP), which is usually not expressed in healthy adult mammalian tissues. FAP has been shown to be elevated in vitro and in situ in glioblastoma cells , suggesting that CAFs expressing FAP might also play a functional role in malignant brain tumors. This research project aims at better characterizing the links between areas of increased FAPI uptake within glioblastomas and the local level of tumor aggressiveness. This will be done by comparing the distribution of their anatomical locations uptake within the tumor with the distribution of the uptake of other markers of local tumor aggressiveness such as amino-acid PET (FET), and MRI measures of cerebral blood flow such as arterial spin labelling (ASL) or perfusion-weighted echo-planar images . Ultimately, when possible, neuroimaging data will be compared with pathology findings from targeted brain biopsy samples or material from ablative surgery. Furthermore, this study will provide the necessary first step towards more large scale studies evaluating the potential use of 177Lu-FAPI as therapeutic agent in glioblastoma.

Conditions

Glioblastoma

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

patients with a brain lesion suspected of glioblastoma based on imaging with a FAPI PET-MR before s

Group Type: OTHER

FAPI PET/MR

Intervention Type: DIAGNOSTIC_TEST

FAPI PET/MR prior surgery or during recurrence suspiscion

patients with suspected glioblastoma recurrence in their follow-up.

Group Type: OTHER

FAPI PET/MR

Intervention Type: DIAGNOSTIC_TEST

FAPI PET/MR prior surgery or during recurrence suspiscion

Interventions

FAPI PET/MR

FAPI PET/MR prior surgery or during recurrence suspiscion

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Age above or equal to 18 years
• Patients with a brain lesion suspected of glioblastoma based on neuroimaging data or patients with suspected recurrence of glioblastoma
• ECOG performance status ≤ 3
• Signed Informed Consent form (ICF) obtained prior to any study related procedure.

Exclusion Criteria

• Pregnant and/or lactating women.
• Subject with a significant medical, neuro-psychiatric, or surgical condition, currently uncontrolled by treatment, which, in the principal investigator's opinion, may interfere with completion of the study.
• Claustrophobic patient
• Known hypersensitivity reactions to the FAPI or to any excipients, or to gadolinium-based contrast agents (GBCAs).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Jules Bordet

Brussels, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Amélie Castiaux, MD

Role: CONTACT

amelie.castiaux@hubruxelles.be

02.555.81.93

Loubna TARAJI, MS

Role: CONTACT

loubna.taraji@hubruxelles.be

02.541.37.81

Facility Contacts

Irina Ortansa Vierasu, MD

Role: primary

o-i.vierasu@hubruxelles.be

02.555.82.80

Loubna TARAJI, MS

Role: backup

Other Identifiers

IJB-NM-GlioFAPI

Identifier Type: -

Identifier Source: org_study_id