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NCT Number: NCT04212910

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Ospedale San Raffaele

Milan, 20153, Italy

Location status: Recruiting

Location contact

Alice Bergamini, MD

SUB_INVESTIGATOR

Gabriele Ironi, MD

PRINCIPAL_INVESTIGATOR

Stephanie Steidler

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. MRI evaluation

    Time frame: 0-2 years

    Measure tumor volume and correlate to surgical specimen

  2. MRI imaging

    Time frame: 0-2 years

    Changes in ADC normale versus tumor myometrium

  3. MRI imaging evaluation

    Time frame: 0-2 years

    Depth of myometrial invasion

  4. DCE-MRI perfusion parameters

    Time frame: 0-2 years

    Define tumor perfusion in normal versus tumor myometrium

  5. MRI

    Time frame: 0-2 years

    positive lymph node evaluation

  6. PET imaging evaluation

    Time frame: 0-2 years

    PET positive lymph nodes

  7. PET imaging

    Time frame: 0-2 years

    Tumor/positive lymph node/metastases SUV values

Secondary outcomes

  1. Measure tumor angiogenesis

    Time frame: 0-2 years

    angiogenesis marker, CD1

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

    Time frame: 0-5 years

    Imaging derived parameters correlated with histopathology

Study contacts

Contact information is provided by the study sponsor or research team.

Stephanie Steidler, PhD

CONTACT

[email protected]

+39022643 ext. 6111

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2027
First posted
Dec 30, 2019
Registry last updated
Apr 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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