Actively Recruiting
[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer
Led by Aalborg University Hospital · Updated on 2025-01-30
50
Participants Needed
1
Research Sites
580 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Newly diagnosed with biopsy verified ovarian cancer or highly suspected to have ovarian cancer based on gynecological cancer MDT
- Deemed resectable and operable at 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
You will not qualify if you...
- 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 or unable to fit within the imaging gantry
- History of allergic reactions or hypersensitivity to 18F-FDG or 68Ga-FAPI-46
- Severe claustrophobia unresponsive to oral anxiolytics
- Medical conditions or circumstances that may reduce data reliability or study completion
- Pregnant, lactating, or breastfeeding women
- Potential pregnant women of childbearing potential not using effective contraceptives
- Inability to remain still for the duration of the examination
AI-Screening
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Trial Site Locations
Total: 1 location
1
Aalborg University Hospital
Aalborg, North Denmark, Denmark, 9000
Actively Recruiting
Research Team
M
Morten Bentestuen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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