Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
ConditionEndometrium Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorIRCCS San Raffaele
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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).
Trial population
Patients with biopsy proven endometrial cancer presenting to the Institution's Gynecology Unit.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
MRI evaluation
Measure tumor volume and correlate to surgical specimen
Time frame
0-2 years2
MRI imaging
Changes in ADC normale versus tumor myometrium
Time frame
0-2 years3
MRI imaging evaluation
Depth of myometrial invasion
Time frame
0-2 years4
DCE-MRI perfusion parameters
Define tumor perfusion in normal versus tumor myometrium
Time frame
0-2 yearsSecondary outcomes
1
Measure tumor angiogenesis
angiogenesis marker, CD1
Time frame
0-2 years2
Correlate PET and MRI derived functional and morphological parameters with histology
Imaging derived parameters correlated with histopathology
Time frame
0-5 yearsSponsors and contacts
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Source ClinicalTrials.gov