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

NCT07119294 | Recruiting

• 1 other identifier: IJB-NM-GlioFAPI
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Keywords

glioblastoma; FAPI PET/CT

Outcome Measures

Primary Outcomes (2)

• To compare the FAPI uptake within the tumor using quantitative measures (SUVmax, SUVmean, and volume) with the uptake of other markers of local tumor aggressiveness such as amino-acid PET and MRI data.

  up to 4 weeks : from enrollment until surgery date or the end of recurrence follow up

• To compare FAPI tumor uptake (SUVmax, SUVmean) with FAP expression based on anatomopathological analysis (Immunohistochemistry) from targeted brain biopsy samples or material from ablative surgery

  up to 4 weeks : from enrollment until anapathological analysis

Secondary Outcomes (1)

• To compare FAPI uptake (SUVmax, SUVmean, Volume) and amino-acid PET uptake in case of tumor recurrence and in case of radionecrosis

  up to 4 weeks : from enrollment to FET PET exam date

Study Arms (2)

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

OTHER

Diagnostic Test: FAPI PET/MR

patients with suspected glioblastoma recurrence in their follow-up.

OTHER

Diagnostic Test: FAPI PET/MR

Interventions

FAPI PET/MR DIAGNOSTIC_TEST

FAPI PET/MR prior surgery or during recurrence suspiscion

patients with a brain lesion suspected of glioblastoma based on imaging with a FAPI PET-MR before s; patients with suspected glioblastoma recurrence in their follow-up.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, 1070, Belgium

RECRUITING

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Central Study Contacts

Amélie Castiaux, MD

CONTACT

02.555.81.93; amelie.castiaux@hubruxelles.be

Loubna TARAJI, MS

CONTACT

02.541.37.81; loubna.taraji@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Patients with a brain lesion suspected of glioblastoma based on imaging will receive a FAPI PET-MR before surgery, matched with the usual examinations (MRI and FET PET-CT). * Patients with suspected glioblastoma recurrence in their follow-up: a FAPI PET/MR, matched with the usual examinations (MRI and FET PET-CT).

Study Record Dates

• First Submitted: July 15, 2025
• First Posted: August 13, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 13, 2025

Record last verified: 2025-07

Locations

BE (1)