NCT05903807CompletedPhase 2
68Ga-FAPI PET/CT: The Diagnostic Accuracy for Primary Staging and Re-staging of Patients with Ovarian Cancer
Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Mar 2026
Brief summary (registry, in English)
1. Compare the diagnostic accuracy of FAPI PET/CT to FDG PET/CT on a lesion basis at primary staging and restaging (after neoadjuvant chemotherapy) 2. Explore how an added FAPI PET/CT influences the patient management at primary staging and at restaging 3. Investigate the feasibility of FAPI PET/CT at restaging (after chemotherapy) 4. Explore the potential limitations of FAPI PET/CT in tumor deposits 5. Evaluate the safety of 68Ga-FAPI-46 injection
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 50 (actual)
- First submitted
- 22 Jun 2023
- Start date
- 17 Nov 2023
- Lead sponsor
- Aalborg University Hospital
- Diseases
- Ovarian cancer
- NCT number
- NCT05903807
- EU CT number
- 2023-505938-98-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 50
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- Patients with non-resectable, inoperable, or recurrent ovarian cancer
- History of allergic reactions / hypersensitivity attributed to 18F-FDG or 68Ga-FAPI-46
- 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
Lab values
- 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)
Other
- Inability to remain still for the duration of the examination
- Subject weighing more than 180 kg (weight limit scanner) or unable to fit within the imaging gantry
- Severe claustrophobia unresponsive to oral anxiolytics
- Pregnant, lactating, or breastfeeding women
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Aalborg University Hospital Coordinator of this site? Confirm its status | Aalborg | Denmark | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.