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

April 14, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

370

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a diagnosis of indeterminate adnexal masses after ultrasonography that will undergo to an MRI examination can be included in this study

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluation of generalizability of the Cambridge Score through external validations
Time Frame: Through study completion, an average of 3 years
Through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluation of Cambridge Score when diagnosed by different readers
Time Frame: Through study completion, an average of 3 years
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
Through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2021

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

March 29, 2023

First Submitted That Met QC Criteria

April 14, 2023

First Posted (Actual)

April 18, 2023

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

April 14, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 4298

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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