RecruitingPhase 2NCT05903807

[68Ga]Ga-FAPI-46 PET/CT in Ovarian Cancer

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


Sponsor

Aalborg University Hospital

Enrollment

50 participants

Start Date

Nov 17, 2023

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing a newer PET scan tracer ([68Ga]Ga-FAPI-46, which targets tumor-associated fibroblasts) with the standard FDG PET scan in people with newly diagnosed ovarian cancer, to see if it can better detect how far the cancer has spread before surgery. **You may be eligible if...** - You are 18 or older and can read and understand Danish - You have a new diagnosis of ovarian cancer confirmed by biopsy, or strong clinical suspicion of ovarian cancer based on specialist evaluation - You are planned for surgery with the goal of removing all cancer (with or without chemotherapy first) - You are physically and mentally able to participate **You may NOT be eligible if...** - Your cancer is inoperable, has recurred, or cannot be surgically removed - You need immediate surgery or are in an emergency - You have had another cancer in the past 5 years (excluding non-melanoma skin cancer) - You weigh more than 180 kg or cannot fit in the scanner - You have had allergic reactions to similar imaging agents Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-FAPi-46

Ovarian cancer patients undergo 68Ga-FAPI-46 at primary staging and at restaging


Locations(1)

Aalborg University Hospital

Aalborg, North Denmark, Denmark

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NCT05903807


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