Clincosm LogoSign in Get a demo

MARF-ESC: Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05808933
Collaborator
(none)
150
Enrollment
1
Location
65.4
Anticipated Duration (Months)
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this observational prospective study is to investigate the role of Magnetic Resonance Fingerprinting in preoperative assessment of early cervical cancer

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    150 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Magnetic Resonance Fingerprinting for Preoperative Evaluation of Lymphovascular Space Invasion in Early Stage Cervical Cancer
    Actual Study Start Date :
    Jun 20, 2022
    Anticipated Primary Completion Date :
    Dec 1, 2027
    Anticipated Study Completion Date :
    Dec 1, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Association between T1-, T2- and ADC-maps and LVSI status [3 months]

    Secondary Outcome Measures

    1. Correlation between T1-, T2- and ADC-maps and DFS and OS [3 years]

    2. Correlation between Radiomics-based analysis and LVSI status and 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 cervical cancer FIGO stage IA-IIA undergoing surgery;

    • Women aged >18 years old;

    • Signed Informed Consent.

    Exclusion Criteria:

    • Concurrent malignancies at other sites;

    • Previous history of neoplasm;

    • Refusal to sign written informed consent

    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:
    NCT05808933
    Other Study ID Numbers:
    • 4988
    First Posted:
    Apr 12, 2023
    Last Update Posted:
    Apr 12, 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:
    Uterine Cervical Neoplasms

    Study Results

    No Results Posted as of Apr 12, 2023