NCT04212910

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Jul 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Jul 2019Feb 2027

Study Start

First participant enrolled

July 23, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 30, 2019

Completed
6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2027

Expected
Last Updated

April 12, 2024

Status Verified

April 1, 2024

Enrollment Period

6.4 years

First QC Date

December 24, 2019

Last Update Submit

April 11, 2024

Conditions

Endometrium Cancer

Keywords

endometriumcancerPET-MRIstratification

Outcome Measures

Primary Outcomes (7)

  • MRI evaluation

    Measure tumor volume and correlate to surgical specimen

    0-2 years

  • MRI imaging

    Changes in ADC normale versus tumor myometrium

    0-2 years

  • MRI imaging evaluation

    Depth of myometrial invasion

    0-2 years

  • DCE-MRI perfusion parameters

    Define tumor perfusion in normal versus tumor myometrium

    0-2 years

  • MRI

    positive lymph node evaluation

    0-2 years

  • PET imaging evaluation

    PET positive lymph nodes

    0-2 years

  • PET imaging

    Tumor/positive lymph node/metastases SUV values

    0-2 years

Secondary Outcomes (2)

  • Measure tumor angiogenesis

    0-2 years

  • Correlate PET and MRI derived functional and morphological parameters with histology

    0-5 years

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemales patients with endometrial cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Ospedale San Raffaele

Milan, 20153, Italy

RECRUITING

Related Publications (3)

  • 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: 22349717BACKGROUND

  • 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: 20130510BACKGROUND

  • 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.

    PMID: 41595203DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Surgically removed endometrium and lymphnodes

MeSH Terms

Conditions

Endometrial NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Stephanie Steidler, PhD

CONTACT

+39022643steidler.stephanie@hsr.it

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Radiology Department

Study Record Dates

First Submitted

December 24, 2019

First Posted

December 30, 2019

Study Start

July 23, 2019

Primary Completion

December 31, 2025

Study Completion (Estimated)

February 28, 2027

Last Updated

April 12, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)