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CAMBRIDGE: Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a MRI Protocol Without Contrast: Validation of the Cambridge Score

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS (Other)
Overall Status
Recruiting
CT.gov ID
NCT05815992
Collaborator
(none)
370
Enrollment
1
Location
39
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this prospective observational study is to evaluate the accuracy and to validate the Cambridge Score,a Test Index to predict the malignancy of the ovarian lesions on the basis of an MRI examination without contrast

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    370 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Accuracy of the Characterization of Adnexal Masses, Indeterminate at Ultrasonography, Using a Magnetic Resonance Imaging Protocol Without Contrast: Validation of the Cambridge Score
    Actual Study Start Date :
    Sep 1, 2021
    Anticipated Primary Completion Date :
    Dec 1, 2024
    Anticipated Study Completion Date :
    Dec 1, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Evaluation of generalizability of the Cambridge Score through external validations [Through study completion, an average of 3 years]

    Secondary Outcome Measures

    1. Evaluation of Cambridge Score when diagnosed by different readers [Through study completion, an average of 3 years]

    2. Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI [Through study completion, an average of 3 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;

    • Indeterminate adnexal masses at the ultrasonography;

    • Signed Informed Consent.

    Exclusion Criteria:

    • Diagnosis of an extraovary mass;

    • Synchronous tumors;

    • Previous history of neoplasy.

    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:
    NCT05815992
    Other Study ID Numbers:
    • 4298
    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