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

NCT06061874 | Recruiting

• 1 other identifier: IJB-NM-FAPeCa1
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer; Peritoneal Carcinomatosis

Keywords

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

Outcome Measures

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)

  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.

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

Secondary Outcomes (2)

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

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

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

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

Study Arms (1)

FAPI PET/CT

EXPERIMENTAL

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.

Diagnostic Test: FAPI PET/CT

Interventions

FAPI PET/CT DIAGNOSTIC_TEST

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

FAPI PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Institut Jules Bordet

Brussels, Belgium

RECRUITING

MeSH Terms

Conditions

Neoplasms; Peritoneal Neoplasms; Colorectal Neoplasms; Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Abdominal Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Digestive System Diseases; Peritoneal Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Patrick Flamen

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Loubna Taraji Schiltz

CONTACT

+32 (0) 2 541 37 81; loubna.taraji@hubruxelles.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2023
• First Posted: September 29, 2023
• Study Start: May 30, 2023
• Primary Completion: June 1, 2025
• Study Completion: December 1, 2025
• Last Updated: March 31, 2025

Record last verified: 2025-03

Locations

BE (1)