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

Phase 1

Recruiting

Conditions: Ovarian Cancer
MedDRA version: 20.0Level: PTClassification code: 10033128Term: Ovarian cancer Class: 100000004864
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]
Therapeutic area: Diseases [C] - Neoplasms [C04]

Registration Number: CTIS2023-505938-98-00

Lead Sponsor: Aalborg University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

Patients with non-resectable, inoperable, or recurrent ovarian cancer, Potential pregnant women of childbearing potential not using effective contraceptives. Potential pregnancy will be ascertained by a pregnancy test (urine humane choriogonadotropin (HCG)) or serum b-HCG) within 48 hours prior to the FAPI PET/CT (see study protocol), Inability to remain still for the duration of the examination, Patients with an imminent need for surgery or in an emergency, Known concurrent other malignancy within the previous 5 years other than non-melanoma skin cancer, Patients not suited for surgery or neoadjuvant chemotherapy followed by surgery, Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry, History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46, Severe claustrophobia unresponsive to oral anxiolytics, Subjects with any medical condition or other circumstances that, in the opinion of the Investigator, would significantly decrease the reliability of data, achievement of study objectives or completing the study, Pregnant, lactating, or breastfeeding women