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NCT Number: NCT06061874

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FAPI PET/CT

Diagnostic Test

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

Primary outcomes

  1. Correlation of the Ga68-FAPI PET/CT derived PCI (peritoneal cancer index) score with the intraoperative PCI based on histopathology of resected specimen (the reference standard)

    Time frame: Through completion of post-surgical pathological examination, up to 2 years since the study initiation

    Intraoperative PCI validated by histopathology performed on resected peritoneal metastases obtained during peritoneal cytoreductive surgery/explorative laparoscopy or laparotomy will be correlated with Ga68-FAPI PET/CT derived PCI.

Secondary outcomes

  1. Comparison of PCI obtained with Ga68-FAPI PET/CT to the PCI calculated on standard preoperative imaging.

    Time frame: Through completion of imaging examinations, up to 2 years since the study initiation

    PCI calculated on standard preoperative imaging (MRI and FDG PET/CT) will be correlated with Ga68-FAPI PET/CT derived PCI.

  2. Assessment of the impact of neoadjuvant chemotherapy on the FAPI expression of target lesions at baseline.

    Time frame: Through completion of post-neoadjuvant chemotherapy FAPI PET examination,up to 2 years since the study initiation

    Subgroup: Patients receiving neoadjuvant chemotherapy Treatment-induced change in the total peritoneal tumor volume and uptake intensity of FAPI on PET/CT will be assessed and correlated to histopathological findings.

Study contacts

Contact information is provided by the study sponsor or research team.

Loubna Taraji Schiltz

CONTACT

[email protected]

+32 (0) 2 541 37 81

Sponsors and collaborators

Lead sponsor

Jules Bordet Institute

Other

Registry information

Official study title

Ga68-labeled Fibroblast Activation Protein Inhibitor-46 (Ga68-FAPI-46) PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis

Acronym: FAPeCa

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Sep 29, 2023
Registry last updated
Mar 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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