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Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

NCT ID: NCT06061874

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

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-30

Study Completion Date

2025-12-31

Brief Summary

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This is a prospective, phase II, non-randomized clinical imaging trial. Ga68-FAPI-46 is a novel radiotracer used in PET/CT imaging, targeting a protein of the tumor microenvironment called FAP (Fibroblast activation protein).

The aim of the study is to assess the accuracy of Ga68-FAPI-46 PET/CT for preoperative assessment of peritoneal carcinomatosis in colorectal and ovarian cancer.

Detailed Description

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Fibroblast activation protein (FAP) is a type II transmembrane glycoprotein expressed on the surface of cancer-associated fibroblasts (CAFs) in the stroma of various tumor entities. Recently, radiolabeled molecules targeting the FAP, called FAP inhibitors (FAPI) labelled with Gallium-68, have been developed for molecular imaging with PET/CT (positron emission tomography/computed tomography). This radiotracer often presents a higher cancer lesion detectability than F18-FDG (fluorodeoxyglucose), partly thanks to its higher tumour-to-background ratio achieved by a low background activity, particularly in the brain, abdominal cavity and liver. These advantages have resulted in a superior sensitivity of Ga68-FAPI PET/CT over F18-FDG and higher SUV (standardized uptake value) in evaluating various types of cancer. In this context, Ga68-FAPI PET/CT seems promising to further study as a clinical imaging modality for preoperative assessment of peritoneal carcinomatosis.

In this study, the investigators correlate Ga68-FAPI PET/CT findings in terms of peritoneal involvement with intraoperative findings based on histopathology and try to find out how accurate Ga68-FAPI PET/CT is for the preoperative assessment of peritoneal carcinomatosis.

Conditions

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Cancer Peritoneal Carcinomatosis

Keywords

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colorectal cancer ovarian cancer peritoneal carcinomatosis fibroblast activation protein inhibitor positron emission tomography FAPI-46 PET FAPI PET/CT fibroblast activation protein

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FAPI PET/CT

Patients with known or suspected peritoneal metastases from colorectal and ovarian cancers scheduled for complete cytoreductive surgery undergo FAPI PET/CT before the planned surgery.

In the target population, patients receiving neoadjuvant chemotherapy undergo FAPI PET/CT both before and after chemotherapy.

Group Type EXPERIMENTAL

FAPI PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Histologically proven colorectal and ovarian cancer.
* Known or suspected peritoneal metastases from the tumour of origin.
* Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
* ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
* Signed written informed consent obtained before any study-specific screening procedures.

Exclusion Criteria

* Non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work-up
* Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
* Pregnant and lactating women
* Previous or concurrent malignancy diagnosed within the last 3 years except adequately treated in situ carcinoma of the cervix uteri 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

Principal Investigators

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Patrick Flamen

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

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Institut Jules Bordet

Brussels, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Loubna Taraji Schiltz

Role: CONTACT

Phone: +32 (0) 2 541 37 81

Email: [email protected]

Facility Contacts

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Loubna Taraji Schiltz

Role: primary

Other Identifiers

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IJB-NM-FAPeCa1

Identifier Type: -

Identifier Source: org_study_id