Ovarian TumorNCT02962596
EURAD MRI Classification of US Indeterminate Adnexa Lesions
An observational study of Ovarian Tumor, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Tumor
- What is being tested?
- ADNEXMR SCORING system
- How many people
- 1,340 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to 15 Aug 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 an indeterminate ultrasonographically adnexal mass referred for MR imaging
Who may be able to join
- Patients 18 years of age or older
- With indeterminate ultrasonographic adnexal mass
Who cannot join
- Patients under 18 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: European Multicenter Validation of an ADNEXMR SCORING System for Characterizing Adnexal Masses: EURAD-MR Classification
This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the research.
Read the detailed description
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 patients management. Recently, the coordinating center developed the first MR scoring system named ANDEXMR SCORING system in a retrospective study which is accurate and reproducible. The objectives of this trial 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 included from each participating center. One senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The reader will then classify the mass using ADNEXMR SCORING system.
- Conditions
- Ovarian Tumor
- Being tested
- ADNEXMR SCORING system
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADNEXMR SCORING systemOther
Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reproducibility of the ADNEX MR scoring system between centers
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)
Differences in rate of surgery in women with adnexal lesions in those where the ADNEX MR score is used compared to when it is not used.
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 posted11 Nov 2016 (estimated)
- Study startFeb 2014
- Primary completion14 Oct 2016
- Study completion15 Aug 2018
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth Sadowski, MD, Principal investigator, University of Wisconsin, MadisonIsabelle Thomassin-Naggara, MD, PhD, Study chair, Assistance Publique - Hôpitaux de ParisAndrea Rockall, MD, Study director, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962596
- Sponsor's protocol ID
- 2014-0112
- Other IDs
- A539320, SMPH/RADIOLOGY/RADIOLOGY
- Status last verified
- Mar 2020
- First submitted
- 31 Oct 2016
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Images and associated data will be labeled with a unique study number that identifies the research site and the patient number (e.g. UWisc001). The link to identifiable information will remain at the University of Wisconsin
Publications
Thomassin-Naggara I, Poncelet E, Jalaguier-Coudray A, Guerra A, Fournier LS, Stojanovic S, Millet I, Bharwani N, Juhan V, Cunha TM, Masselli G, Balleyguier C, Malhaire C, Perrot NF, Sadowski EA, Bazot M, Taourel P, Porcher R, Darai E, Reinhold C, Rockall AG. Ovarian-Adnexal Reporting Data System Magnetic Resonance Imaging (O-RADS MRI) Score for Risk Stratification of Sonographically Indeterminate Adnexal Masses. JAMA Netw Open. 2020 Jan 3;3(1):e1919896. doi: 10.1001/jamanetworkopen.2019.19896.
PubMed 31977064
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. 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
- NCT02962596
- Acronym / sponsor ID
- 2014-0112
- Conditions
- Ovarian Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,340 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Feb 2014 (actual)
- Primary completion
- 14 Oct 2016 (actual)
- Study completion
- 15 Aug 2018 (actual)
- First posted
- 11 Nov 2016 (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.
This research is targeting patients with sonographically indeterminate adnexal mass that are being referred for clinical MR imaging. Investigators from the UW will be contributing coded MR images and associated health information (US results, laboratory/pathology results) to the EURAD trial. In addition, outcomes data on each patient will be sent at month 24 of the research.
Detailed description
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 patients management. Recently, the coordinating center developed the first MR scoring system named ANDEXMR SCORING system in a retrospective study which is accurate and reproducible. The objectives of this trial 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 included from each participating center. One senior and one junior radiologists independently analyze the different MR criteria to characterize adnexal masses. The reader will then classify the mass using ADNEXMR SCORING system.
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 an indeterminate ultrasonographically adnexal mass referred for MR imaging
Key inclusion criteria (2 listed)
- Patients 18 years of age or older
- With indeterminate ultrasonographic adnexal mass
Key exclusion criteria (1 listed)
- Patients under 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADNEXMR SCORING systemScoring system used to standardize the imaging report for sonographically indeterminate adnexal masses. | Other | – |
Primary outcome
Reproducibility of the ADNEX MR scoring system between centers
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
Differences in rate of surgery in women with adnexal lesions in those where the ADNEX MR score is used compared to when it is not used.
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Results publication: PubMed 31977064Thomassin-Naggara I, Poncelet E, Jalaguier-Coudray A, Guerra A, Fournier LS, Stojanovic S, Millet I, Bharwani N, Juhan V, Cunha TM, Masselli G, Balleyguier C, Malhaire C, Perrot NF, Sadowski EA, Bazot M, Taourel P, Porcher R, Darai E, Reinhold C, Rockall AG. Ovarian-Adnexal Reporting Data System Magnetic Resonance Imaging (O-RADS MRI) Score for Risk Stratification of Sonographically Indeterminate Adnexal Masses. JAMA Netw Open. 2020 Jan 3;3(1):e1919896. doi: 10.1001/jamanetworkopen.2019.19896.
- Individual participant dataSharing planned: Yes. Images and associated data will be labeled with a unique study number that identifies the research site and the patient number (e.g. UWisc001). The link to identifiable information will remain at the University of Wisconsin
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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.
Elizabeth Sadowski, MD principal investigator
University of Wisconsin, Madison
Isabelle Thomassin-Naggara, MD, PhD study chair
Assistance Publique - Hôpitaux de Paris
Andrea Rockall, MD study director
Imperial College London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Tumor, run by University of Wisconsin, Madison at 1 site in United States.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reproducibility of the ADNEX MR scoring system between centers (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 NCT02962596, 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 Mar 2020.