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

Last updated: March 26, 2025
Sponsor: Jules Bordet Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Carcinoma

Digestive System Neoplasms

Peritoneal Cancer

Treatment

FAPI PET/CT

Clinical Study ID

NCT06061874
IJB-NM-FAPeCa1
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 orwithout neoadjuvant chemotherapy.

  • ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.

  • Signed written informed consent obtained before any study-specific screeningprocedures.

Exclusion

Exclusion Criteria:

  • Non-resectable extra-abdominal metastasis and/or >3 hepatic metastases on standardwork-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 exceptadequately treated in situ carcinoma of the cervix uteri and basal or squamous cellskin cancer.

  • Subjects with another significant medical condition which, in the investigator'sopinion, may interfere with the completion of the study.

Study Design

Total Participants: 80
Treatment Group(s): 1
Primary Treatment: FAPI PET/CT
Phase:
Study Start date:
May 30, 2023
Estimated Completion Date:
December 31, 2025

Study Description

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.

Connect with a study center

  • Institut Jules Bordet

    Brussels,
    Belgium

    Active - Recruiting

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