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

Fondazione Policlinico Universitario Agostino Gemelli IRCCS370 enrolled

Overview

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

Study Type

OBSERVATIONAL

Enrollment

370

Conditions

Adnexal Mass

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Fondazione Policlinico Universitaro "A. Gemelli" IRCCS

Roma, Italy

RECRUITING

Outcomes

Primary Outcomes

Evaluation of generalizability of the Cambridge Score through external validations

Time frame: Through study completion, an average of 3 years

Secondary Outcomes

Evaluation of Cambridge Score when diagnosed by different readers

Time frame: Through study completion, an average of 3 years

Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI

Time frame: Through study completion, an average of 3 years

Data from ClinicalTrials.gov

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