Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

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.

Study Overview

• Status: Recruiting
• Conditions: Endometrium Cancer

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 Type: Observational
• Enrollment (Estimated): 101

Contacts and Locations

• Study Contact: Name: Stephanie Steidler, PhD; Phone Number: 6111 +39022643; Email: steidler.stephanie@hsr.it

Study Locations

• Italy
  • Milano, Italy, 20153
    • Recruiting
    • IRCCS Ospedale San Raffaele
    • Contact: Stephanie Steidler; Email: steidler.stephanie@hsr.it
    • Principal Investigator: Gabriele Ironi, MD
    • Sub-Investigator: Alice Bergamini, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with biopsy proven endometrial cancer presenting to the Institution's Gynecology Unit.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Publications and helpful links

General Publications

• Kitajima K, Kita M, Suzuki K, Senda M, Nakamoto Y, Sugimura K. Prognostic significance of SUVmax (maximum standardized uptake value) measured by [(1)(8)F]FDG PET/CT in endometrial cancer. Eur J Nucl Med Mol Imaging. 2012 May;39(5):840-5. doi: 10.1007/s00259-011-2057-9. Epub 2012 Feb 17.
• Nakamura K, Kodama J, Okumura Y, Hongo A, Kanazawa S, Hiramatsu Y. The SUVmax of 18F-FDG PET correlates with histological grade in endometrial cancer. Int J Gynecol Cancer. 2010 Jan;20(1):110-5. doi: 10.1111/IGC.0b013e3181c3a288.

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2019
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): February 28, 2027

Study Registration Dates

• First Submitted: December 24, 2019
• First Submitted That Met QC Criteria: December 25, 2019
• First Posted (Actual): December 30, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: cancer; endometrium; PET-MRI; stratification
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Uterine Neoplasms; Genital Neoplasms, Female; Uterine Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometrial Neoplasms
• Other Study ID Numbers: PET/MRI-ONCOGYN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No