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

NCT ID: NCT05815992

Last Updated: 2023-04-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 370 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2024-12-31

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

Conditions

Adnexal Mass

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, , Italy

Site Status: RECRUITING

Countries

Italy

Facility Contacts

Giacomo G Avesani, MD

Role: primary

giacomo.avesani@policlinicogemelli.it

0630156054 ext. +39

Other Identifiers

4298

Identifier Type: -

Identifier Source: org_study_id