Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

NCT ID: NCT04212910

Last Updated: 2024-04-12

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 101 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-07-23
• Study Completion Date: 2027-02-28

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.

Conditions

Endometrium Cancer

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IRCCS San Raffaele

OTHER

Sponsor Role: lead

Responsible Party

Francesco De Cobelli

Head, Radiology Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

IRCCS Ospedale San Raffaele

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Stephanie Steidler, PhD

Role: CONTACT

steidler.stephanie@hsr.it

+39022643 ext. 6111

Facility Contacts

Stephanie Steidler

Role: primary

steidler.stephanie@hsr.it

References

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.

Reference Type: BACKGROUND

PMID: 22349717 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20130510 (View on PubMed)

Other Identifiers

PET/MRI-ONCOGYN

Identifier Type: -

Identifier Source: org_study_id