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RecruitingNCT07119294GlioFAPIUpdated Aug 13, 2025

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

An interventional study of FAPI PET/MR in Glioblastoma, sponsored by Jules Bordet Institute. Recruiting at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-08-13.

Sponsored by Jules Bordet Institute · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Glioblastoma

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Keywords

  • glioblastoma
  • FAPI PET/CT
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In context

Glioblastoma

1,920 studies on the registry are indexed under Glioblastoma; 450 are open to participants now.

This study's planned enrollment of 50 is above the median of 36 across 1,618 interventional studies indexed under Glioblastoma.

Browse Glioblastoma studies →

Lead sponsor

Jules Bordet Institute is the lead sponsor of 103 studies on the registry; 28 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

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

    Diagnostic Test: FAPI PET/MR

  • Other
    patients with suspected glioblastoma recurrence in their follow-up.

    Diagnostic Test: FAPI PET/MR

Interventions

  • Diagnostic testFAPI PET/MR

    FAPI PET/MR prior surgery or during recurrence suspiscion

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What researchers measure

Primary outcomes

  1. 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.

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

  2. 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

    Time frame: 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

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

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Study locations

1 of 1 sites recruiting
  • Institut Jules Bordet
    Brussels, 1070, Belgium
    • Irina Ortansa Vierasu, MD · Contact · o-i.vierasu@hubruxelles.be · 02.555.82.80
    • Loubna TARAJI, MS · Contact
    • Gil Leurquin Sterk, MD · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 13, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07119294
Lead sponsor
Jules Bordet Institute
Responsible party
Sponsor
First posted
Aug 13, 2025
Start date
Aug 2025 (estimated)
Primary completion
Dec 2027 (estimated)
Completion
Jun 2028 (estimated)
Last update
Aug 13, 2025

Study contacts

Amélie Castiaux, MD
Contact
amelie.castiaux@hubruxelles.be
02.555.81.93
Loubna TARAJI, MS
Contact
loubna.taraji@hubruxelles.be
02.541.37.81

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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