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WHOLE BODY: Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05816005
Collaborator
(none)
71
Enrollment
1
Location
35
Anticipated Duration (Months)
2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this prospective observational diagnostic study is to investigate the diagnostic accuracy od extrapelvic disease detection using Whole-body-MRI (WB-MRI) in patients with gynecologic cancer candidate to the pelvic exenteration.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    71 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Performance of Whole Body MRI in Extraplevic Disease Detection in Patients Undergoing Pelvic Exenteration for Gynecological Maligniancies
    Actual Study Start Date :
    Jul 1, 2021
    Anticipated Primary Completion Date :
    Jun 1, 2024
    Anticipated Study Completion Date :
    Jun 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of diagnostic accuracy for extrapelvic disease detection using whole-body MRI [Through study completion, an average of 2 yearS]

    Secondary Outcome Measures

    1. Agreement between WB-MRI and PET-CT in detecting extrapelvic involvement [Through study completion, an average of 2 yearS]

    Eligibility Criteria

    Criteria

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

    • Age > 18 years

    • Written Informed Consent

    • All patients with recurrent gynecological cancer that are planned to undergo pelvic exenteration or laterally extended pelvic resection, both with curative and palliative intent

    • Patients considered fit for srugery

    Exclusion Criteria:

    • Controindication to MRI (Claustrophobia, implanted ferromagnetic materials or foreign objects, Known intolerance or controindication to the MRI contrast agent, cardiac pacemaker)

    • Individuals who are not able or willing to tolerate the required prologed stationary supine position during examination (approximately 40-60 minutes)

    • Patient unable to give 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:
    NCT05816005
    Other Study ID Numbers:
    • 3813
    First Posted:
    Apr 18, 2023
    Last Update Posted:
    Apr 18, 2023
    Last Verified:
    Mar 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Apr 18, 2023