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MARF-E: Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05807672
Collaborator
(none)
150
Enrollment
1
Location
44.3
Anticipated Duration (Months)
3.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

In this context, the aim of this study is to investigate the role of MRF in endometrial cancer. Several applications are possible. Firstly, T1-, T2- and DWI-mappings can be associated to molecular risk group classification, in order to stratify patients' risk without recurring to surgery. MRF parameters can be also correlated to prognosis, both in terms of disease-free survival (DFS) and overall survival (OS).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    MARF-E- Magnetic Resonance Fingerprinting in the Imaging of Endometrial Cancer
    Actual Study Start Date :
    Apr 23, 2022
    Anticipated Primary Completion Date :
    Apr 30, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Outcome Measures

    Primary Outcome Measures

    1. Association between T1-, T2- and diffusion-mappings and risk group classification [3 months]

    Secondary Outcome Measures

    1. Diagnostic accuracy of T1-,T2- and diffusion-mappings deriving from MRF in myometrial invasion detection [3 months]

    2. Correlation between T1-, T2- and diffusion mappings and DFS and OS [3 years]

    3. Diagnostic accuracy of T1-,T2- and diffusion-mappings and pathological nodal involvement [3 months]

    4. Evaluation of Radiomic and Radiogenomic models to predict recurrence in early stage EC and to predict DFS and OS [3 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients with biopsy-proven endometrial cancer;

    • Women aged > 18 years old;

    • Signed Informed consent.

    Exclusion Criteria:

    • Previous history of neoplasm;

    • Concurrent malignancies at other sites.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Fondazione Policlinico Universitaro "A. Gemelli" IRCCS Roma Italy 00168

    Sponsors and Collaborators

    • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    ClinicalTrials.gov Identifier:
    NCT05807672
    Other Study ID Numbers:
    • 4690
    First Posted:
    Apr 11, 2023
    Last Update Posted:
    Apr 11, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Endometrial Neoplasms

    Study Results

    No Results Posted as of Apr 11, 2023