ADNEXMR Scoring System: Impact of an MR Scoring System on Therapeutic Strategy of Pelvic Adnexal Masses

Summary

Background : About 25% of adnexal masses remain indeterminate after transvaginal ultrasonography, as evidenced by the published literature. According to a multicenter study conducted in France by Huchon et al., surgery is mainly indicated based on tumor size and ultrasonographic appearances and a high rate of benignity is finally found at pathology (83.3%). MRI is the most accurate second-line imaging technique for characterizing adnexal masses with an accuracy\>95%. However, among physicians, a debate exists on the relevance of MR imaging to characterize adnexal masses possibly due to the absence of standardization of the MR report. In 2013, the first MR scoring system for adnexal masses named "ADNEXMR score" was developed and found to be accurate, with an AUROC\>0.94 to distinguish benign from malignant adnexal masses. Indeed, our hypothesis is that ADNEXMR score that relays the radiologist's suspicion of malignancy to clinician has the potential aim of improving patient management, in particular by limiting the number of patients undergoing inappropriate surgery.

Main objective: To compare the rate of inappropriate surgery that occurs when patients are managed according to the therapeutic strategy based on ADNEXMR score with the therapeutic strategy performed in clinical routine.

Primary endpoint: The rate of inappropriate surgical intervention during the two first months after MR imaging (i.e. unnecessary diagnostic surgery for benign lesions and incomplete staging for borderline or invasive cancer).

Study design:

* The study is a prospective multicenter randomized diagnostic study. 606 patients will be included by 9 hospitals (17 centers).
* Total duration of the study is 56 months with 32 months for patient inclusions.
* At D0, following informed written consent, patients will be randomized in one of two groups (intervention group or control group). In the intervention group, patients will undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium injection) and functional sequences (perfusion and diffusion-weighted sequences). Prospectively, a senior radiologist analyzes the different MR criteria to characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score. In control group, the complex adnexal mass will be managed according to the standard strategy and treatment plan routinely used by the multidisciplinary team. Clinical, biological, ultrasonographic and/or MR data and the type of treatment will be recorded. If a surgery is required, surgical procedure will be performed within the two months after initial diagnostic imaging (as routinely recommended).

At M6/M12, follow-up will be performed. If the lesion has increased or changed with suspicious criteria, surgery will be performed as routinely recommended in both groups.

At M24, adnexal masses status will be recorded by clinical and imaging follow up.

Conditions

• Patient With Sonographically Indeterminate or Complex Adnexal Mass

Interventions

PROCEDURE

ADNEXMR Scoring System

Patients will undergo a pelvic MR imaging (1.5T or 3T) as routinely performed, including morphological sequences (T2, T1 with and without fat suppression and T1 after dynamic gadolinium injection) and functional sequences (perfusion and diffusion-weighted sequences). Prospectively, a senior radiologist analyzes the different MR criteria to characterize adnexal masses. The reader will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score

OTHER

Standard strategy

In control group, the complex adnexal mass will be managed according to the standard strategy and treatment plan routinely used by the multidisciplinary team.

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Isabelle THOMASSIN-NAGGARA, Dr · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-12-15

Primary Completion

2021-12-31

Completion

2021-12-31

Countries

• France

Study Locations