Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

Recruiting

• Conditions: Endometrium Cancer

• Registration Number: NCT04212910
• Lead Sponsor: IRCCS San Raffaele

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.

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.

Study Timeline

• Study Start: 2019-07-23
• Study First Submitted: 2019-12-24
• Study First Submitted QC: 2019-12-25
• Study First Posted: 2019-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-11
• Last Update Posted: 2024-04-12
• Primary Completion: 2025-12-31
• Study Completion: 2027-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 101

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
MRI imaging evaluation	0-2 years	Depth of myometrial invasion
MRI evaluation	0-2 years	Measure tumor volume and correlate to surgical specimen
MRI imaging	0-2 years	Changes in ADC normale versus tumor myometrium
MRI	0-2 years	positive lymph node evaluation
PET imaging evaluation	0-2 years	PET positive lymph nodes
DCE-MRI perfusion parameters	0-2 years	Define tumor perfusion in normal versus tumor myometrium
PET imaging	0-2 years	Tumor/positive lymph node/metastases SUV values

Secondary Outcome Measures

Name	Time	Method
Correlate PET and MRI derived functional and morphological parameters with histology	0-5 years	Imaging derived parameters correlated with histopathology
Measure tumor angiogenesis	0-2 years	angiogenesis marker, CD1

Trial Locations

Locations (1)

IRCCS Ospedale San Raffaele; 🇮🇹 Milano, Italy