GlioblastomaGlioFAPINCT07119294
Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.
A study testing FAPI PET/MR in people with Glioblastoma, run by Jules Bordet Institute at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- FAPI PET/MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2025to Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Institut Jules Bordet
Brussels, 1070
Irina Ortansa Vierasu, MD, 02.555.82.80, o-i.vierasu@hubruxelles.be
Loubna TARAJI, MS
About this study
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
- Being tested
- FAPI PET/MR
- Keywords
- glioblastoma, FAPI PET/CT
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FAPI PET/MRDiagnostic test
FAPI PET/MR prior surgery or during recurrence suspiscion
| Study group | Role | What they receive |
|---|---|---|
| patients with a brain lesion suspected of glioblastoma based on imaging with a FAPI PET-MR before s | Other | Not described Receives: Diagnostic Test: FAPI PET/MR |
| patients with suspected glioblastoma recurrence in their follow-up. | Other | Not described Receives: Diagnostic Test: FAPI PET/MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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
Measured: up to 4 weeks : from enrollment to FET PET exam date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study startAug 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- * 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).
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jules Bordet Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119294
- Sponsor's protocol ID
- IJB-NM-GlioFAPI
- Acronym
- GlioFAPI
- Status last verified
- Jul 2025
- First submitted
- 15 Jul 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Imaging of Cancer-associated Fibroblasts in Glioblastoma: a FAPI PET/MR Study.
- ClinicalTrials.gov ID
- NCT07119294
- Acronym / sponsor ID
- GlioFAPI / IJB-NM-GlioFAPI
- Conditions
- Glioblastoma
- Keywords
- glioblastoma, FAPI PET/CT
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Jules Bordet InstituteUniversity, hospital or other
- Study start
- Aug 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- * 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).
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FAPI PET/MRFAPI PET/MR prior surgery or during recurrence suspiscion | Diagnostic test | 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. |
Primary outcome
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
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
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FAPI PET/MR in people with Glioblastoma, run by Jules Bordet Institute at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amélie Castiaux, MD (02.555.81.93, amelie.castiaux@hubruxelles.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2025.