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

EU CT nr: 2023-505938-98-00

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.

2023-11-17

2025-11-01

2035-01-01

Recruiting

Early phase I

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 * 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. * Potential pregnant women of childbearing potential \[1\] not using effective contraceptives \[2\]. 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. * Inability to remain still for the duration of the examination 1. Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, i.e., not sterilized (bilateral tubectomy/occlusion, hysterectomy, bilateral oophorectomy) and not post-menopausal. In cases of uncertain menopausal status, serum follicle stimulating hormone (FSH) levels and menstruation history can be assessed 2. Effective contraceptives include sexual abstinence, vasectomized partner, combined hormonal contraception (oral, intravaginal, transdermal), progesterone-only contraceptive (oral, injectable, implantable), or working intrauterine device (hormonal, non-hormonal).

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Fifty consecutive patients newly diagnosed with ovarian cancer are recruited', 'primaryPurpose': 'DIAGNOSTIC', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 50, 'type': 'ESTIMATED'}}

2023-12-11