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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT07119294
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Jules Bordet Institute
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Belgium
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Arms & Interventions

Arms

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

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

Interventions

Diagnostic Test: - FAPI PET/MR

FAPI PET/MR prior surgery or during recurrence suspiscion

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Institut Jules Bordet, Brussels, Belgium

Status

Recruiting

Address

Institut Jules Bordet

Brussels, , 1070

Site Contact

Irina Ortansa Vierasu, MD

[email protected]

02.555.82.80

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