NCT04212910

Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 101 (estimated)
• Sponsor: IRCCS San Raffaele · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endometrial cancer (EC) is the most common gynecological malignancy in high-income countries. Prognosis and treatment are dictated by cancer histological subtype and grade coupled with surgical staging as described by Surgical International Federation of Gynecology and Obstetrics (FIGO) staging system. Surgery is the elective standard treatment and used for staging of EC. The purpose of this study is to collect images from a simultaneous PET/MRI study from which to extrapolate a preoperative, non-invasive, prognostic model.

Detailed description

Magnetic resonance imaging (MRI) is the most frequently used imaging tool in preoperative staging of endometrial cancer. FDG-PET has demonstrated higher sensitivity than MRI in detecting nodal involvement and metastatic disease and is currently used in adjunction to MRI. Distinct MRI and FDG-PET parameters correlate well with tumor aggressiveness and can and have been used as prognostic factors. The Investigators believe that the combination of data from these two imaging techniques, from which different derived tumor features can be extrapolated, can stratify patients in high-risk and low-risk groups already preoperatively. The aim of combined techniques is to collect large amounts of data leveraging advantages of both modalities (MR's strengths in local staging and PET's strengths in nodal staging) in a single scan from which to extrapolate a preoperative, non-invasive, prognostic model.

Conditions

• Endometrium Cancer

Timeline

• Start date: 2019-07-23
• Primary completion: 2025-12-31
• Completion: 2027-02-28
• First posted: 2019-12-30
• Last updated: 2024-04-12

Locations

1 site across 1 country: Italy