Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Endometrium Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- MRI evaluation [Time frame: 0-2 years]
- MRI imaging [Time frame: 0-2 years]
- MRI imaging evaluation [Time frame: 0-2 years]
- DCE-MRI perfusion parameters [Time frame: 0-2 years]
- MRI [Time frame: 0-2 years]
- PET imaging evaluation [Time frame: 0-2 years]
- PET imaging [Time frame: 0-2 years]
Secondary outcome measures (2)
- Measure tumor angiogenesis [Time frame: 0-2 years]
- Correlate PET and MRI derived functional and morphological parameters with histology [Time frame: 0-5 years]
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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Italy · 1 center
- IRCCS Ospedale San Raffaele — Milan
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. PMID 22349717
- 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. PMID 20130510
- Bezzi C, Ironi G, Russo T, Candotti G, Fallanca F, Sabini C, Samanes Gajate AM, Ghezzo S, Bergamini A, Sant'Angelo M, Bocciolone L, Brembilla G, Scifo P, Taccagni G, Catalano OA, Mangili G, Candiani M, De Cobelli F, Chiti A, Mapelli P, Picchio M. [18F]FDG PET/MRI in Endometrial Cancer: Prospective Evaluation of Preoperative Staging, Molecular Characterization and Prognostic Assessment. Cancers (Ba PMID 41595203
Identifiers
NCT: NCT04212910 · PET/MRI-ONCOGYN