Endometrium Cancer
Conditions
Keywords
endometrium, cancer, PET-MRI, stratification
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.
Interventions
None listed
Sponsors
IRCCS San Raffaele
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET imaging | 0-2 years | Tumor/positive lymph node/metastases SUV values |
| MRI | 0-2 years | positive lymph node evaluation |
| PET imaging evaluation | 0-2 years | PET positive lymph nodes |
| 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 imaging evaluation | 0-2 years | Depth of myometrial invasion |
| DCE-MRI perfusion parameters | 0-2 years | Define tumor perfusion in normal versus tumor myometrium |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Italy
Contacts
Primary ContactStephanie Steidler, PhD
Outcome results
None listed