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

NCT02664597 | Unknown

• 2 other identifiers: P 140911AOM 14207
• Study Type: interventional
• Target: 377
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ADNEXMR SCORING system; MRI; adnexal masses

Outcome Measures

Primary Outcomes (1)

• Rate of inappropriate surgical intervention

  To compare the rate of inappropriate surgery that occurs when patients are managed according to the therapeutic strategy based on ADNEXMR SCORING system with the therapeutic strategy performed in clinical routine according to European Society of Medical Oncology guidelines (i.e. ultrasonography, CA125 +/-MR imaging).

  the two first months after MR imaging

Secondary Outcomes (2)

• Percentage of surgical complications or anesthetic complications

  During the 24 months of patient follow-up

• Percentage of missed cancer diagnosis at initial staging

  During the 24 months of patient follow-up

Study Arms (2)

Standard strategy

SHAM COMPARATOR

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

Other: Standard strategy

ADNEXMR SCORING

EXPERIMENTAL

In the intervention group, patients will undergo a pelvic MR imaging as routinely performed, including morphological sequences and functional sequences. Prospectively, the radiologist will classify the mass using ADNEXMR SCORING system and the patient will be managed according to the score.

Procedure: ADNEXMR Scoring System

Interventions

ADNEXMR Scoring System PROCEDURE

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

ADNEXMR SCORING

Standard strategy OTHER

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

Standard strategy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient ≥ 18 years old, with no upper limit
• With sonographically indeterminate or complex adnexal mass. Complex or indeterminate adnexal mass is defined as :
• an adnexal lesion with a solid component which must be characterized or
• a cystic adnexal lesion for which a solid component cannot easily be formally excluded by ultrasonograghy
• Patient covered by health insurance
• Informed written consent

You may not qualify if:

• Pacemaker, ferromagnetic materials, or foreign body at risk of mobilization or any other contra-indication to MR imaging.
• Intolerance to iodinated or gadolinium contrast agents, or severe renal insufficiency (GFR \<30 ml/min/1.73m²).
• Infertile women (women who unsuccessfully tried to have child during 2 years)
• Pelvic pain which conduct to a surgical indication regardless of imaging results
• Patient deprived of liberty or under legal protection measure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Department Radiology Hospital Tenon

Paris, 75020, France

Location

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Study Officials

• Isabelle THOMASSIN-NAGGARA, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 27, 2016
• Study Start: December 15, 2016
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: October 20, 2021

Record last verified: 2021-10

Locations

FR (1)