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Molecular Imaging of FAP Expressing Cancer-associated Fibroblasts in NSCLC Treated With Immune-checkpoint Inhibitors

NCT ID: NCT06107608

Last Updated: 2025-03-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

58 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-13

Study Completion Date

2027-12-01

Brief Summary

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Evaluation of the relation between baseline fibroblast activation protein (FAP) expression based on Ga-FAPI uptake with patient outcome among NSCLC patients receiving immunotherapy for recurrent/metastatic disease.

Detailed Description

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Fibroblast activation protein (FAP), a type II membrane glycoprotein, is selectively expressed by cancer-associated fibroblasts (CAFs) in more than 90% of epithelial carcinomas. FAP also regulates antitumor immune response. For these reasons, FAP is an attractive target and molecular imaging biomarker to assess CAFs and the tumour's landscape before and during immunotherapy. The PET radiotracer 68Ga-FAPI (Fibroblast activation protein inhibitor) allows the visualisation and quantification of CAFs.This study will use a non-invasive technique to assess CAFs before and during immunotherapy and to evaluate diverse predictive biomarkers in a prospective setting studying simultaneously CAFs (using 68Ga-FAPI) and cfDNA.

Conditions

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Non Small Cell Lung Cancer

Keywords

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Immunotherapy FAPI-46 Non Small Cell Lung Cancer PET PET/CT fibroblast activation protein fibroblast activation protein inhibitor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

molecular imaging of FAP
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FAPI PET/CT

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT in patients with NSCLC with an indication for immunotherapy

Group Type EXPERIMENTAL

FAPI PET/CT

Intervention Type PROCEDURE

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Interventions

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FAPI PET/CT

The radiopharmaceutical 68Gallium-FAPI-46 (FAPI) is injected intravenously for molecular imaging of FAP expression with FAPI PET/CT.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Age above 18 years.
* Pathologically- proven non-small-cell lung cancer (NSCLC).
* Proposed for treatment with anti-PD-(L)1 alone or in combination with chemotherapy and/or anti-CTLA4 in the advanced setting.
* ECOG Performance status ≤2.
* Patient's written informed consent obtained prior to any study procedure.

Exclusion Criteria

* Surgery and/or radiotherapy to thoracic region within the last 8 weeks or anti-cancer systemic therapy within the last 2 weeks.
* Epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK) and c-ros oncogene (ROS1) mutations.
* Pregnant and lactating women
* Previous or concurrent malignancy diagnosed within the last 2 years except adequately treated in situ carcinoma of the cervix uteri, localised (T1N0) low grade (Gleason score 6) prostate cancer undergoing active surveillance and basal or squamous cell skin cancer.
* Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Jules Bordet Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Facility Contacts

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Loubna Taraji Schiltz

Role: primary

Other Identifiers

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IJB-MN-LIFE1

Identifier Type: -

Identifier Source: org_study_id