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Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

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

At a glance

Status
Ongoing, recruiting
Phase
Therapeutic exploratory (Phase II)
Sponsor
Aalborg University Hospital
Enrolment target
50
Start
11 Sep 2023

What is this study about?

Compare the FAPI PET/CT and FDG PET/CT findings in primary tumor, regional lymph nodes and distant metastases to a histopathological reference standard where the sensitivity, specificity, positive predicative value, and negative predicative values of the PET/CTs are determined, both at primary staging and at restaging, Compare the cancer stage as determined by FAPI PET/CT compared to conventional imaging (including FDG PET/CT) at primary staging and at restaging (after neoadjuvant chemotherapy). The proportion of patients downstaged, unchanged stage, and upstaged, due to the added FAPI PET/CT are determined., Investigate what proportion of patients will be (hypothetically) treated differently due to an added FAPI PET/CT at primary staging and at restaging (after neoadjuvant chemotherapy) by the treating clinicians, Investigate the feasibility of FAPI PET/CT at restaging (after neoadjuvant chemotherapy) by comparing the FAPI PET/CT signal after neoadjuvant chemotherapy to a histopathological reference standard, Investigate the correlation between FAPI PET/CT SUV values and extent of FAP expressing CAFs in tumor deposits through volume-density estimation and immunohistochemical assessment of surgical specimens., Note reported discomfort, and measure heart rate and blood pressure before and at specific timepoints after FAPI infusion.

Who may be eligible?

Age 18 Years to any · Sex: Female

Locations (1)

  • Denmark

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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