Trial Information

European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"

All patients with an indeterminate ultrasonographically adnexal mass referred for MR imaging
will be consecutively included in each center.

Inclusion Criteria

- Patient ≥ 18 years old

- With indeterminate ultrasonographic adnexal mass

- Informed consent

Non inclusion Criteria

- Pregnant women

- Pacemaker, ferromagnetic materials, or foreign body at risk of mobilization

- Intolerance to iodinated or gadolinium contrast agents, or severe renal insufficiency
(GFR <30 ml/min/1.73m²).

Objectives • Primary objective: Evaluate if ADNEXMR SCORING system is relevant for reporting
pelvic magnetic resonance imaging (MRI) examinations performed for characterization of
sonographically indeterminate adnexal masses in an external prospective multicenter study

• Secondary objectives and endpoints: Evaluate

1. The potential impact of applying the score to the therapeutic strategy, in particular
to measure the possible reduction in oncologic surgery in benign cases

2. If ADNEXMR SCORING system improves reproducibility of MR report for characterization
of adnexal masses

3. If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any
clinical and ultrasonographic data

Main endpoint Joint analysis of true negative and false negative rates according to ADNEXMR
SCORING system as compared to the histological results (or follow-up outcome, see "reference
standard", below) with an evaluation of the sensitivity and the specificity of the score