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Clinical Trial · NCT06061874
Ga68-FAPI-46 PET/CT for Preoperative Assessment of Peritoneal Carcinomatosis
Overview
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.
Sponsor
Jules Bordet Institute
Phase
N/A
Contacts
Loubna Taraji Schiltz (CONTACT)
loubna.taraji@hubruxelles.be
+32 (0) 2 541 37 81
Patrick Flamen (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT06061874Drug / Compound
FAPI-46
Isotope(s):
GALLIUM-68
Radioisotope: Ga-68
Theranostic Role: PET Imaging
T1/2 (Half-Life): 68 minutes
Decay Mode: POSITRON β+ (88.9%), GAMMA, ELECTRON CAPTURE (8.7%)
Energy: Beta: max 1.9 MeV Gamma 1.1 MeV, 511 keV
Range: N/A
Decay Daughters: Zn68 (Stable)
Status: FDA Approvals: NETSPOT® (2016), LOCAMETZ® (2022), ILLUCIX® (2021)
Target(s):
- FAP
Ligand Class: Small Molecules
Chelator: DOTA
Eligibility
Inclusion
- Scheduled for peritoneal complete cytoreductive surgery with curative intent with or without neoadjuvant chemotherapy.
- Known or suspected peritoneal metastases from the tumour of origin.
- ECOG (Eastern Cooperative Oncology Group) Performance status ≤2.
- Histologically proven colorectal and ovarian cancer.
Exclusion
- Non-resectable extra-abdominal metastasis and/or \>3 hepatic metastases on standard work-up
- Pregnant and lactating women
- Known chronic inflammatory conditions including the intestinal system (eg. inflammatory bowel disease, Crohn's disease)
- Subjects with another significant medical condition which, in the investigator's opinion, may interfere with the completion of the study.
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