TheranosticTrials.org

Clinical Trial · NCT05903807

[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer

Overview

Fifty (n=50) patients with newly diagnosed ovarian cancer will undergo FAPI PET/CTs in addition to routine diagnostic workup (including FDG PET/CT) at primary staging and restaging. The FAPI PET/CT results will be compared to conventional imaging (including FDG PET/CT) using histopathology as reference standard, and the diagnostic accuracy will be determined. FAP-immunohistochemistry will be conducted in surgical specimens. FAPI PET/CT's impact on patient management and the prognostic value of FAPI PET/CT will be evaluated.

Sponsor

Aalborg University Hospital

Phase

Phase 2

Contacts

Morten Bentestuen, MD (CONTACT)

m.bentestuen@rn.dk

+4597665500

ClinicalTrials.gov

NCT05903807

Drug / Compound

FAPI-46

Isotope(s):
Target(s):
  • FAP
Ligand Class: Small Molecules
Chelator: DOTA

Eligibility

Inclusion

  • Can read and understand Danish
  • * Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer (based on all data presented at the gynecological cancer MDT) and referred to primary staging with FDG PET/CT
  • Considered physically and mentally able to participate in the research project
  • 18-years or older and able to consent to project participation
  • Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy

Exclusion

  • Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
  • Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery
  • Patients with an imminent need for surgery or in an emergency
  • * Patients with non-resectable, inoperable, or recurrent ovarian cancer
  • Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer