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

Recruiting

• Conditions: Adnexal Mass

• Registration Number: NCT05815992
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2021-09-01
• Status Verified: 2023-03
• Study First Submitted: 2023-03-29
• Study First Submitted QC: 2023-04-14
• Last Update Submitted: 2023-04-14
• Study First Posted: 2023-04-18
• Last Update Posted: 2023-04-18
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 370

Inclusion Criteria

• Age > 18 years;
• Indeterminate adnexal masses at the ultrasonography;
• Signed Informed Consent.

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Exclusion Criteria

• Diagnosis of an extraovary mass;
• Synchronous tumors;
• Previous history of neoplasy.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of generalizability of the Cambridge Score through external validations	Through study completion, an average of 3 years

Secondary Outcome Measures

Name	Time	Method
Evaluation of Cambridge Score when diagnosed by different readers	Through study completion, an average of 3 years
Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI	Through study completion, an average of 3 years

Trial Locations

Locations (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS; 🇮🇹 Roma, Italy