Ovarian TumorEURADNCT01738789
EURAD-MR Classification : European Multicenter Study
An observational study of Ovarian Tumor, run by Société d'Imagerie de la Femme at 24 sites in 8 countries.
Trial summary
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Tumor
- How many people
- 1,340 participants
- Where
- 24 sitesin 8 countries
- Study dates
- Mar 2013to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center
Who may be able to join
- Patient ≥ 18 years old
- With sonographically indeterminate adnexal mass
- Informed consent
Who cannot join
- Pregnant women (relative contra indication for gadolinium injection)
- 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).
Trial locations and contacts
24 sites in 8 countries.
24 sites in 8 countries
France12 sites
Centre Oscar Lambret
Lille
Hopital de la Timone
Marseille
Institut Paoli Calmettes
Marseille
Hopital de Lapeyronie
Montpellier
Tenon Hospital
Paris, 75020
Centre imagerie Pyramides
Paris
Hopital Européen Georges Pompidou
Paris
Hopital Lariboisière
Paris
Hôpital de la Pitié-Salpétrière
Paris
Institut Curie - Huguenin
Paris
Hopital de Valenciennes
Valenciennes
Institut Gustave Roussy
Villejuif
United Kingdom5 sites
Addenbrokes hospital
Cambridge
Barts Health NHS trust
London
Imperial College Healthcare
London
University College London
London
Steeping Hill hospital
Stockport
Portugal2 sites
Hospital da Luz
Lisbon
Instituto Portuges de Oncologia de Lisboa Francisco Gentil
Lisbon
About this study
Official title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility.
This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.
Read more
Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice.
Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years.
Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.
Read the detailed description
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
- The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in oncologic surgery in benign cases
- If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
- 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
- Conditions
- Ovarian Tumor
- Keywords
- Adnexal masses, Magnetic resonance imaging, Ovarian tumor
- Medical subject headings
- Ovarian Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
External validation of Adnex MR scoring system
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
Measured: 24 months
Secondary outcomes (3)
Potential reduction of unnecessary surgery
The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in unnecessary surgery in benign cases
Measured: 24 months
Reproducibility of the score
If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
Measured: 24 months
Comparison between a blinded and an unblinded radiologist regarding sonographic data
If ADNEXMR SCORING system is as accurate if the radiologist is blinded from any clinical and ultrasonographic data
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2012 (estimated)
- Study startMar 2013
- Primary completionMar 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ovarian TumorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,340 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société d'Imagerie de la Femme
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Thomassin-Naggara, Société d'Imagerie de la Femme
- Investigators
- Isabelle Thomassin-Naggara, MD, PhD, Study chair, Assistance Publique des Hopitaux de Paris, Université Pierre et Marie CurieAndrea Rockall, MD, Study director, Imperial College LondonMarc Bazot, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01738789
- Sponsor's protocol ID
- SIFEM-2013-1
- Acronym
- EURAD
- Status last verified
- Jul 2017
- First submitted
- 28 Nov 2012
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Wengert GJ, Dabi Y, Kermarrec E, Jalaguier-Coudray A, Poncelet E, Porcher R, Thomassin-Naggara I, Rockall AG; EURAD Study Group. O-RADS MRI Classification of Indeterminate Adnexal Lesions: Time-Intensity Curve Analysis Is Better Than Visual Assessment. Radiology. 2022 Jun;303(3):566-575. doi: 10.1148/radiol.210342. Epub 2022 Mar 1.
PubMed 35230183
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: "EURAD-MR Classification"
- ClinicalTrials.gov ID
- NCT01738789
- Acronym / sponsor ID
- EURAD / SIFEM-2013-1
- Conditions
- Ovarian Tumor
- Keywords
- Adnexal masses, Magnetic resonance imaging, Ovarian tumor
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- Société d'Imagerie de la FemmeUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 30 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
An adnexal mass is the most common indication for gynaecological surgery . Pre operative characterization is crucial and a scoring system would be useful to standardize the imaging report and thus, improve patient management. Recently, our center developed the first MR scoring system named ADNEXMR SCORING system in a retrospective study which is accurate and reproducible (1). Our objectives are to perform an external prospective validation of this scoring system, to evaluate its potential impact on therapeutic strategy and to test its reproducibility.
This is a prospective large multicenter study. All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center. Then, patients will undergo a routine pelvic MR imaging. Prospectively, one senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The MR report will be issued as standard and the patient will be managed accordingly. Then, the reader will classify the mass using ADNEXMR SCORING system. The classification will be compared to the reference standard as defined below. The reproducibility of the classification will be tested between the junior and the senior radiologist. After anonymisation, images will be analyzed by another senior radiologist of another center blinded from any clinical or ultrasonographical data and correlated with the reference standard.
Reference standard: Reference standard will be surgical procedure with histology or standard clinical follow-up depending on most appropriate routine practice.
Sample size: The sample size was computed to ensure a power of at least 90% (with a two-sided type I error rate of 5%) to conclude that SCORE 2 and 3 and SCORE 4 and 5 would have a different PPV. It would thus be necessary to have at least 569 patients classified as SCORE 2, 259 as SCORE 3, 52 as SCORE 4 and 51 as SCORE 5 (18). Given the prevalences, and assuming 6% of patients would be classified, as SCORE 1 and 10% would be lost to follow-up, 1340 patients will be included in this study to insure a probability of at least 95% to obtain the aforementioned number of patients in each score category. The inclusion period will last 18 months (extension for a period of 12 months) and monitoring will continue for 2 years.
Thomassin Naggara I., et al. Development and preliminary validation of an MRI Scoring system for Adnexal Masses. Radiology 2013, May;267(2):432-43.
Detailed description
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
- The potential impact of applying the score to the therapeutic strategy, in particular to measure the possible reduction in oncologic surgery in benign cases
- If ADNEXMR SCORING system improves reproducibility of MR report for characterization of adnexal masses
- 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a sonographically indeterminate adnexal mass referred for MR imaging will be consecutively included in each center
Key inclusion criteria (3 listed)
- Patient ≥ 18 years old
- With sonographically indeterminate adnexal mass
- Informed consent
Key exclusion criteria (3 listed)
- Pregnant women (relative contra indication for gadolinium injection)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
External validation of Adnex MR scoring system
Time frame: 24 months
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
3 secondary outcomes
Potential reduction of unnecessary surgery
Time frame: 24 months
Reproducibility of the score
Time frame: 24 months
Comparison between a blinded and an unblinded radiologist regarding sonographic data
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2017.
- Derived from this study: PubMed 35230183Wengert GJ, Dabi Y, Kermarrec E, Jalaguier-Coudray A, Poncelet E, Porcher R, Thomassin-Naggara I, Rockall AG; EURAD Study Group. O-RADS MRI Classification of Indeterminate Adnexal Lesions: Time-Intensity Curve Analysis Is Better Than Visual Assessment. Radiology. 2022 Jun;303(3):566-575. doi: 10.1148/radiol.210342. Epub 2022 Mar 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Isabelle Thomassin-Naggara, MD, PhD study chair
Assistance Publique des Hopitaux de Paris, Université Pierre et Marie Curie
Andrea Rockall, MD study director
Imperial College London
Marc Bazot, MD principal investigator
Assistance Publique - Hôpitaux de Paris
24 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Tumor, run by Société d'Imagerie de la Femme at 24 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France, United Kingdom, Portugal, Austria, Croatia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
External validation of Adnex MR scoring system (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01738789, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2017.