FAPI PET/MR imaging of fibroblast activity in glioblastoma
Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.
This will try a FAPI PET/MR scan to image fibroblast activation in adults with a suspected or recurrent glioblastoma.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Jules Bordet Institute Academic / other |
| Locations | 1 site (Brussels) |
| Trial ID | NCT07119294 on ClinicalTrials.gov |
What this trial studies
This single-center interventional imaging protocol uses a radiotracer that binds fibroblast activation protein (FAP) combined with PET/MR to visualize cancer-associated fibroblasts in and around brain tumors. Eligible adults with a brain lesion suspected to be glioblastoma or with suspected recurrence will undergo the FAPI PET/MR scan, including standard MR sequences and tracer administration. Images will be analyzed to map FAP expression and compare tracer uptake with conventional imaging features and clinical information. The procedure excludes pregnant or lactating patients and those with known hypersensitivity to the tracer or gadolinium contrast.
Who should consider this trial
Good fit: Adults aged 18 or older with a brain lesion suspected to be glioblastoma or with suspected recurrence, ECOG performance status ≤3, who can undergo PET/MR and provide informed consent are ideal candidates.
Not a fit: Pregnant or breastfeeding patients, those with uncontrolled major medical or neuropsychiatric conditions, claustrophobia preventing MR, or known hypersensitivity to the tracer or gadolinium are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the technique could improve tumor visualization and help distinguish active tumor from treatment-related changes, potentially guiding surgical or treatment decisions.
How similar studies have performed: FAPI PET has shown promising imaging results in several non-brain cancers and FAP expression has been reported in glioblastoma, but imaging cancer-associated fibroblasts in brain tumors is a relatively new approach with limited validation to date.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Brussels
- Institut Jules Bordet — Brussels, Belgium (Recruiting)
Study contacts
- Study coordinator: Amélie Castiaux, MD
- Email: amelie.castiaux@hubruxelles.be
- Phone: 02.555.81.93
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.