Actively Recruiting

Phase 2
Age: 18Years +
FEMALE
NCT05903807

[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

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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