NCT04212910 Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
| NCT ID | NCT04212910 |
| Status | Recruiting |
| Phase | — |
| Sponsor | IRCCS San Raffaele |
| Condition | Endometrium Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 101 participants |
| Start Date | 2019-07-23 |
| Primary Completion | 2025-12-31 |
Trial Parameters
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Brief 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.
Eligibility Criteria
Inclusion Criteria: * histopathological confirmation of a primary endometrial cancer * age \> 18 years * no contraindication to surgery (comorbidity, contraindication or lack of consent) * no contraindication to preoperative imaging * visible tumor at imaging * signed inform consent. Exclusion Criteria: * patients unsuitable for surgical intervention (comorbidity, contraindication or lack of consent, poor performance status) * age \< 18 years, c) inability to complete the needed imaging examination (ie, severe claustrophobia) * any additional medical condition that may significantly interfere with study compliance * all the contraindication for MRI (ie, pacemaker).
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