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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05815992

Acronym

CAMBRIDGE

Enrollment

370

Registered

2023-04-18

Start date

2021-09-01

Completion date

2024-12-31

Last updated

2023-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Mass

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

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Italy

Outcome results