Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
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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 Design
Outcome Measures
Primary Outcome Measures
- MRI imaging evaluation [0-2 years]
Measure tumor volume and correlate to surgical specimen
- MRI imaging evaluation [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
- MRI imaging evaluation [0-2 years]
positive lymph node evaluation
- PET imaging evaluation [0-2 years]
PET positive lymph nodes
- PET imaging evaluation [0-2 years]
Tumor/positive lymph node/metastases SUV values
Secondary Outcome Measures
- Measure tumor angiogenesis [0-2 years]
angiogenesis marker, CD1
- Correlate PET and MRI derived functional and morphological parameters with histology [0-5 years]
Imaging derived parameters correlated with histopathology
Eligibility Criteria
Criteria
Inclusion Criteria:
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histopathological confirmation of a primary endometrial cancer
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age > 18 years
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no contraindication to surgery (comorbidity, contraindication or lack of consent)
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no contraindication to preoperative imaging
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visible tumor at imaging
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signed inform consent.
Exclusion Criteria:
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patients unsuitable for surgical intervention (comorbidity, contraindication or lack of consent, poor performance status)
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age < 18 years, c) inability to complete the needed imaging examination (ie, severe claustrophobia)
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any additional medical condition that may significantly interfere with study compliance
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all the contraindication for MRI (ie, pacemaker).
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | IRCCS Ospedale San Raffaele | Milano | Italy | 20153 |
Sponsors and Collaborators
- IRCCS San Raffaele
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Kitajima K, Kita M, Suzuki K, Senda M, Nakamoto Y, Sugimura K. Prognostic significance of SUVmax (maximum standardized uptake value) measured by [¹⁸F]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.
- PET/MRI-ONCOGYN