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ADNEXMR Scoring System: Impact of an MR Scoring System on Therapeutic Strategy of Pelvic Adnexal Masses (ASCORDIA01)

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ClinicalTrials.gov Identifier: NCT02664597
Recruitment Status : Recruiting
First Posted : January 27, 2016
Last Update Posted : March 19, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.


Condition or disease Intervention/treatment Phase
Patient With Sonographically Indeterminate or Complex Adnexal Mass Procedure: ADNEXMR Scoring System Other: Standard strategy Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 606 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: ADNEXMR Scoring System: Impact of an MR Scoring System on Therapeutic Strategy of Pelvic Adnexal Masses
Actual Study Start Date : December 15, 2016
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Arm Intervention/treatment
Sham Comparator: 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.
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.

Experimental: ADNEXMR SCORING
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
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




Primary Outcome Measures :
  1. Rate of inappropriate surgical intervention [ Time Frame: the two first months after MR imaging ]
    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).


Secondary Outcome Measures :
  1. Percentage of surgical complications or anesthetic complications [ Time Frame: During the 24 months of patient follow-up ]
    To compare the routine therapeutic strategy and the therapeutic strategy based on ADNEXMR SCORING system on therapeutic morbidity and mortality based on the percentage of surgical complications (gastro-intestinal fistula, lymphocyst, septic complications, pulmonary embolism, death, parietal hernia) and anaesthesic complications

  2. Percentage of missed cancer diagnosis at initial staging [ Time Frame: During the 24 months of patient follow-up ]
    To compare the routine therapeutic strategy and the therapeutic strategy based on ADNEXMR SCORING system on the percentage of missed cancer diagnosis at initial staging



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Pregnant and breast feeding women (relative contra indication for gadolinium injection), pregnancy test will be performed before inclusion for women of childbearing age
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02664597


Contacts
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Contact: Isabelle THOMASSIN-NAGGARA, Dr 01 56 01 64 53 ext +33 isabelle.thomassin@aphp.fr

Locations
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France
Department Radiology Hospital Tenon Recruiting
Paris, France, 75020
Contact: Emile DARAI, Pr    0156017319 ext +33    emile.darai@aphp.fr   
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Isabelle THOMASSIN-NAGGARA, Dr Assistance Publique - Hôpitaux de Paris

Publications of Results:

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02664597     History of Changes
Other Study ID Numbers: P 140911
AOM 14207 ( Other Grant/Funding Number: DGOS )
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Assistance Publique - Hôpitaux de Paris:
ADNEXMR SCORING system
MRI
adnexal masses