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

Adnexal Mass Clinical Trial

— CAMBRIDGE  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05815992
• Other study ID #: 4298
• Status: Recruiting
• Start date: September 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 370
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Mass

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitaro "A. Gemelli" IRCCS	Roma

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of generalizability of the Cambridge Score through external validations		Through study completion, an average of 3 years
Secondary	Evaluation of Cambridge Score when diagnosed by different readers		Through study completion, an average of 3 years
Secondary	Evaluation of diagnostic agreement between the Non-contrast and contrast-enhanced MRI		Through study completion, an average of 3 years