This phase IV trial studies how well an investigational scan called fluciclovine F18 positron emission tomography (PET) works in diagnosing cervical or endometrial cancer. Fluciclovine F18 is a type of radioactive diagnostic agent that is injected into the patient and then taken up by tumor cells, which can then be visualized by using PET imaging scans. The purpose of this study is to determine the diagnostic potential of fluciclovine F18 PET when compared to standard of care imaging scans.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03423082.
PRIMARY OBJECTIVES:
I. To study the pharmacokinetics of fluciclovine F18 (fluciclovine) PET in women with cervical and uterine cancers.
II. To characterize physiologic uptake pattern of the uterus and ovaries when these are not affected by tumor.
III. To identify the optimal time window for the quantitative analysis of fluciclovine primary and pelvic nodal disease.
IV. To correlate the time-activity curve pattern of the primary lesion with histopathologic tumor grading.
V. To compare diagnostic performance of fluciclovine PET and fludeoxyglucose F-18 (FDG) PET.
VI. To compare textural heterogeneity of the primary between fluciclovine PET and FDG PET.
OUTLINE:
Patients receive fluciclovine F18 intravenously (IV) then undergo a PET scan. Approximately 20 minutes later, patients receive gadobenate dimeglumine IV and undergo an MRI scan. The total time for both scans is 60 minutes.
Lead OrganizationUniversity of Pittsburgh Cancer Institute (UPCI)
Principal InvestigatorNghi C Nguyen
