[68Ga]Ga-FAPI-46 PET/CT: the Diagnostic Accuracy for Primary Staging and Re-staging of Patients with Ovarian Cancer

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• Deemed resectable and operable at the MDT with or without neoadjuvant chemotherapy

• Considered physically and mentally able to participate in the research project

• 18-years or older and able to consent to project participation

• Can read and understand Danish

Locations
Other Locations
Denmark
Aalborg University Hospital
RECRUITING
Aalborg
Contact Information
Primary
Morten Bentestuen, MD
m.bentestuen@rn.dk
+4597665500
Time Frame
Start Date: 2023-11-17
Estimated Completion Date: 2035-01-01
Participants
Target number of participants: 50
Treatments
Experimental: Ovarian cancer or high risk of ovarian cancer
Patients with newly diagnosed ovarian cancer or high risk of ovarian cancer undergo FAPI PET/CT in addition to conventional imaging
Related Therapeutic Areas
Sponsors
Leads: Aalborg University Hospital

This content was sourced from clinicaltrials.gov