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Endometrium CancerNCT04212910

Stratifying Endometrial Cancer Patients Using a PET/MRI Prognostic Model

An observational study of Endometrium Cancer, run by IRCCS San Raffaele at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Endometrium Cancer
How many people
86 participants
Where
1 siteItaly
Study dates
23 Jul 2019to 1 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • IRCCS Ospedale San Raffaele

    Milan, 20153

Other trials in Italy

About this study

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.

Read the 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.

Keywords
endometrium, cancer, PET-MRI, stratification
Medical subject headings
Endometrial Neoplasms, Neoplasms

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRI evaluation

    Measure tumor volume and correlate to surgical specimen

    Measured: 0-2 years

  2. MRI imaging

    Changes in ADC normale versus tumor myometrium

    Measured: 0-2 years

  3. MRI imaging evaluation

    Depth of myometrial invasion

    Measured: 0-2 years

  4. DCE-MRI perfusion parameters

    Define tumor perfusion in normal versus tumor myometrium

    Measured: 0-2 years

  5. MRI

    positive lymph node evaluation

    Measured: 0-2 years

  6. PET imaging evaluation

    PET positive lymph nodes

    Measured: 0-2 years

  7. PET imaging

    Tumor/positive lymph node/metastases SUV values

    Measured: 0-2 years

Secondary outcomes (2)

  1. Measure tumor angiogenesis

    angiogenesis marker, CD1

    Measured: 0-2 years

  2. Correlate PET and MRI derived functional and morphological parameters with histology

    Imaging derived parameters correlated with histopathology

    Measured: 0-5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2019
  2. Study start23 Jul 2019
  3. Primary completion28 Feb 2025
  4. Study completion1 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04212910
Sponsor's protocol ID
PET/MRI-ONCOGYN
Status last verified
Sep 2026
First submitted
24 Dec 2019
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    PubMed 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.

    PubMed 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 (Basel). 2026 Jan 16;18(2):280. doi: 10.3390/cancers18020280.

    PubMed 41595203

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrium Cancer, run by IRCCS San Raffaele at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRI evaluation (time frame: 0-2 years). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04212910, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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