Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple RulesIOTA-MRINCT02836275
Value of MRI in the Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules
A study testing Diffusion/Perfusion-weighted Magnetic Resonance Imaging in people with Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules, run by KU Leuven at 1 site in Belgium.
Trial summary
Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to classify an ovarian tumor as benign or malignant. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules
- What is being tested?
- Diffusion/Perfusion-weighted Magnetic Resonance Imaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- Oct 2016to Dec 2020
- Phase
- Interventional
- 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
Who may be able to join
- Any adult woman with an adnexal mass unclassified by gynecological ultrasound using the IOTA Simple Rules.
- Patient planned for surgery.
Who cannot join
- Any lesion with conclusive result on gynecological ultrasound using the IOTA Simple Rules.
- Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
- No surgery performed or surgery performed >120 days after ultrasound scan.
- Denial or withdrawal of informed consent.
- Contra-indication for MRI
- Current pregnancy
- Age < 18 years
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Vincent Vandecaveye, PhD
About this study
Official title: Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. Recently the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors.
The aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Other aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images.
Read more
The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational.
The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center.
The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician.
Read the detailed description
Ovarian cancer is a common and lethal disease for which early detection and treatment in high volume centers and by specialized clinicians is known to improve survival. Hence, accurate methods to preoperatively characterize the nature of an ovarian tumor are pivotal. The IOTA group has suggested Simple ultrasound based rules that can be used to classify adnexal masses as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. The benefit of using MRI in sonographically indeterminate masses has been evaluated previously. However, the ability of MRI to correctly classify tumors unclassifiable by the IOTA Simple Rules has not been examined. The group of Thomassin-Naggara et al has recently developed the ADNEXMR SCORING system, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors.
The primary aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Secondary aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images.
The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational.
The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center.
At first, a standardized patient history will be registered, followed by a standardized transvaginal gynecological ultrasound. All variables required for the diagnostic models as well as the subjective diagnosis and certainty of diagnosis by the examiner will be collected. Quality control is provided by the fact that all examiners involved in gynecological ultrasound have completed IOTA-training and succeeded in a certification test. All data will be registered in an online Clinical Data Miner system (CDM).
In case that the results of the Simple Rules are inconclusive, and surgery is justifiable, the patient will be informed about the IOTA-MRI study. If the patient agrees to participate, the inclusion criteria are met and if there are no contra-indications, the patient will be referred to the radiology department of the same center or an affiliated center.
Second, at the radiology department, a standardized pelvic MRI examination will take place (diffusion- and perfusion- weighted sequences). All the variables that are needed for the classification of the ADNEXMR SCORING system as well as the subjective diagnosis of the radiologist, will be registered in CDM. Quality control in this part is provided by the fact that all radiologists involved in the study are certified by EURAD (EURopean ADnex mr score).
The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician. In case of malignancy, staging of the tumor will be reported by the International Federation of Gynecology and Obstetrics (FIGO) classification. All results will be registered in CDM.
- Being tested
- Diffusion/Perfusion-weighted Magnetic Resonance Imaging
- Keywords
- Adnexal Diseases, Ovary, Ovarian Neoplasms, Ovarian Cysts, Ovarian Diseases, Ultrasonography, Ultrasonography, Doppler, Magnetic Resonance Imaging, Diffusion Magnetic Resonance Imaging, Diagnosis, Early Diagnosis, Early Detection of Cancer, Genital Neoplasms, Female, Genital Diseases, Female, Urogenital Neoplasms, Cysts, Endocrine System Diseases, Gonadal Disorders, Neoplasms, Endocrine Gland Neoplasms
- Medical subject headings
- Adnexal Diseases, Ovarian Neoplasms, Ovarian Cysts, Ovarian Diseases, Disease, Genital Neoplasms, Female, Genital Diseases, Female, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diffusion/Perfusion-weighted Magnetic Resonance ImagingOther
| Study group | Role | What they receive |
|---|---|---|
| Perfusion and diffusion-weighted MRI | Experimental | Not described Receives: Other: Diffusion/Perfusion-weighted Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of the ADNEXMR SCORING system in classifying adnexal masses as malignant or benign using MRI with diffusion- and perfusion-weighted sequences in masses unclassified by the IOTA Simple Rules.
Measured: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
Secondary outcomes (3)
Proportion of malignant masses per level of the ADNEXMR SCORING system.
Measured: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
Interobserver reproducibility of ADNEXMR SCORING system using MRI with diffusion- and perfusion-weighted sequences by comparing lesion characterization (interpretation) and region of interest delineation on the perfusion curve.
This will take place later using stored images.
Measured: During estimated recruitment period of 2 years.
Accuracy of the suggested specific diagnosis made on the basis of the MRI images.
Measured: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startOct 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple RulesStudies of the same condition, open and under way.
- More trials run by KU LeuvenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dirk Timmerman, KU Leuven
- Investigators
- Isabelle Thomassin-Naggara, MD, PhD, Study chair, Department of Radiology, Hôpital Tenon, Paris, FRANCEAndrea Rockall, MBBS, MRCP, FRCR, Study chair, Imperial College London, London, UNITED KINGDOMTom Bourne, MD, PhD, Study chair, Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOMBen Van Calster, MSc, PhD, Study chair, Department Development & Regeneration, KU Leuven, Leuven, BELGIUMIgnace Vergote, MD, PhD, Study chair, Department of Obstetrics and Gynecology, University Hospitals KU Leuven, Leuven, BELGIUM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02836275
- Sponsor's protocol ID
- IOTA-MRI s59142
- Acronym
- IOTA-MRI
- Status last verified
- Apr 2020
- First submitted
- 14 Jul 2016
- Last updated
- 14 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Woo YL, Kyrgiou M, Bryant A, Everett T, Dickinson HO. Centralisation of services for gynaecological cancers - a Cochrane systematic review. Gynecol Oncol. 2012 Aug;126(2):286-90. doi: 10.1016/j.ygyno.2012.04.012. Epub 2012 Apr 13.
PubMed 22507534Engelen MJ, Kos HE, Willemse PH, Aalders JG, de Vries EG, Schaapveld M, Otter R, van der Zee AG. Surgery by consultant gynecologic oncologists improves survival in patients with ovarian carcinoma. Cancer. 2006 Feb 1;106(3):589-98. doi: 10.1002/cncr.21616.
PubMed 16369985Vernooij F, Heintz AP, Witteveen PO, van der Heiden-van der Loo M, Coebergh JW, van der Graaf Y. Specialized care and survival of ovarian cancer patients in The Netherlands: nationwide cohort study. J Natl Cancer Inst. 2008 Mar 19;100(6):399-406. doi: 10.1093/jnci/djn033. Epub 2008 Mar 11.
PubMed 18334710Earle CC, Schrag D, Neville BA, Yabroff KR, Topor M, Fahey A, Trimble EL, Bodurka DC, Bristow RE, Carney M, Warren JL. Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients. J Natl Cancer Inst. 2006 Feb 1;98(3):172-80. doi: 10.1093/jnci/djj019.
PubMed 16449677Timmerman D, Testa AC, Bourne T, Ameye L, Jurkovic D, Van Holsbeke C, Paladini D, Van Calster B, Vergote I, Van Huffel S, Valentin L. Simple ultrasound-based rules for the diagnosis of ovarian cancer. Ultrasound Obstet Gynecol. 2008 Jun;31(6):681-90. doi: 10.1002/uog.5365.
PubMed 18504770Bernardin L, Dilks P, Liyanage S, Miquel ME, Sahdev A, Rockall A. Effectiveness of semi-quantitative multiphase dynamic contrast-enhanced MRI as a predictor of malignancy in complex adnexal masses: radiological and pathological correlation. Eur Radiol. 2012 Apr;22(4):880-90. doi: 10.1007/s00330-011-2331-z. Epub 2011 Nov 18.
PubMed 22095438Kinkel K, Lu Y, Mehdizade A, Pelte MF, Hricak H. Indeterminate ovarian mass at US: incremental value of second imaging test for characterization--meta-analysis and Bayesian analysis. Radiology. 2005 Jul;236(1):85-94. doi: 10.1148/radiol.2361041618. Epub 2005 Jun 13.
PubMed 15955864Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Darai E, Bazot M. Adnexal masses: development and preliminary validation of an MR imaging scoring system. Radiology. 2013 May;267(2):432-43. doi: 10.1148/radiol.13121161. Epub 2013 Mar 6.
PubMed 23468574Thomassin-Naggara I, Toussaint I, Perrot N, Rouzier R, Cuenod CA, Bazot M, Darai E. Characterization of complex adnexal masses: value of adding perfusion- and diffusion-weighted MR imaging to conventional MR imaging. Radiology. 2011 Mar;258(3):793-803. doi: 10.1148/radiol.10100751. Epub 2010 Dec 30.
PubMed 21193596Installe AJ, Van den Bosch T, De Moor B, Timmerman D. Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research. JMIR Med Inform. 2014 Oct 20;2(2):e28. doi: 10.2196/medinform.3251.
PubMed 25600863Heintz AP, Odicino F, Maisonneuve P, Quinn MA, Benedet JL, Creasman WT, Ngan HY, Pecorelli S, Beller U. Carcinoma of the ovary. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S161-92. doi: 10.1016/S0020-7292(06)60033-7. No abstract available.
PubMed 17161157
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Ovarian Masses Unable to Classify With Ultrasound Using the International Ovarian Tumor Analysis (IOTA) Simple Rules: Value of Pelvic MRI With Perfusion- and Diffusion-weighted Imaging
- ClinicalTrials.gov ID
- NCT02836275
- Acronym / sponsor ID
- IOTA-MRI / IOTA-MRI s59142
- Keywords
- Adnexal Diseases, Ovary, Ovarian Neoplasms, Ovarian Cysts, Ovarian Diseases, Ultrasonography, Ultrasonography, Doppler, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- KU LeuvenUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 19 Jul 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.
Gynecological ultrasound is well known as the preferred exam to assess patients with ovarian tumors. The International Ovarian Tumor Analysis (IOTA) group developed the 'Simple Rules' to classify an ovarian tumor as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. Recently the ADNEXMR SCORING system was developed, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors.
The aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Other aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images.
The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational.
The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center.
The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician.
Detailed description
Ovarian cancer is a common and lethal disease for which early detection and treatment in high volume centers and by specialized clinicians is known to improve survival. Hence, accurate methods to preoperatively characterize the nature of an ovarian tumor are pivotal. The IOTA group has suggested Simple ultrasound based rules that can be used to classify adnexal masses as benign or malignant. In about 1/5 of patients the Simple Rules give an inconclusive result and therefore a suitable second line test is necessary. The benefit of using MRI in sonographically indeterminate masses has been evaluated previously. However, the ability of MRI to correctly classify tumors unclassifiable by the IOTA Simple Rules has not been examined. The group of Thomassin-Naggara et al has recently developed the ADNEXMR SCORING system, this is the first Magnetic Resonance Imaging (MRI) score system that focuses on ovarian tumors.
The primary aim of this prospective study is to evaluate the performance of pelvic MRI examination with perfusion -and diffusion- weighted sequences and the application of the ADNEXMR SCORING system in ovarian tumors that cannot be classified by the IOTA Simple Rules (regarding the prediction of malignancy). Secondary aims are the determination of the malignancy rate per ADNEXMR SCORING system class, the evaluation of interobserver reproducibility and the assessment of the accuracy of the specific diagnosis based on MRI images.
The study is a multicenter prospective study. In centers where perfusion -and diffusion weighted MRI imaging is not a part of clinical routine in unclassifiable ovarian masses based on ultrasound, the study is considered to be interventional. However, in other centres, depending on the local guidelines, perfusion -and diffusion weighted MRI imaging can be standard of care. In these centres, the study can be considered to be observational.
The IOTA-MRI project is linked to the IOTA study. In this multicenter study different diagnostic ultrasound algorithms are tested prospectively in patients with an ovarian mass prior to surgery. This study allows to define a subgroup of patients in which Simple Rules are inconclusive, in other words the population eligible for inclusion in the IOTA-MRI project. We plan to include 250 patients in the IOTA-MRI study. Patients will be included consecutively, yet only after completing the informed consent. Recruitment will take 2 years of time as of the start of the individual center.
At first, a standardized patient history will be registered, followed by a standardized transvaginal gynecological ultrasound. All variables required for the diagnostic models as well as the subjective diagnosis and certainty of diagnosis by the examiner will be collected. Quality control is provided by the fact that all examiners involved in gynecological ultrasound have completed IOTA-training and succeeded in a certification test. All data will be registered in an online Clinical Data Miner system (CDM).
In case that the results of the Simple Rules are inconclusive, and surgery is justifiable, the patient will be informed about the IOTA-MRI study. If the patient agrees to participate, the inclusion criteria are met and if there are no contra-indications, the patient will be referred to the radiology department of the same center or an affiliated center.
Second, at the radiology department, a standardized pelvic MRI examination will take place (diffusion- and perfusion- weighted sequences). All the variables that are needed for the classification of the ADNEXMR SCORING system as well as the subjective diagnosis of the radiologist, will be registered in CDM. Quality control in this part is provided by the fact that all radiologists involved in the study are certified by EURAD (EURopean ADnex mr score).
The gold standard is the histopathology diagnosis of the mass within 120 days after ultrasound evaluation. The surgical approach is chosen by the managing clinician. In case of malignancy, staging of the tumor will be reported by the International Federation of Gynecology and Obstetrics (FIGO) classification. All results will be registered in CDM.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perfusion and diffusion-weighted MRI | Experimental | Other: Diffusion/Perfusion-weighted Magnetic Resonance Imaging |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any adult woman with an adnexal mass unclassified by gynecological ultrasound using the IOTA Simple Rules.
- Patient planned for surgery.
Key exclusion criteria (7 listed)
- Any lesion with conclusive result on gynecological ultrasound using the IOTA Simple Rules.
- Cysts that are deemed to be clearly physiological and less than 3 cm in maximum diameter are not eligible for inclusion.
- No surgery performed or surgery performed >120 days after ultrasound scan.
- Denial or withdrawal of informed consent.
- Contra-indication for MRI
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 |
|---|---|---|
| Diffusion/Perfusion-weighted Magnetic Resonance Imaging | Other | Perfusion and diffusion-weighted MRI |
Primary outcome
The sensitivity and specificity of the ADNEXMR SCORING system in classifying adnexal masses as malignant or benign using MRI with diffusion- and perfusion-weighted sequences in masses unclassified by the IOTA Simple Rules.
Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
3 secondary outcomes
Proportion of malignant masses per level of the ADNEXMR SCORING system.
Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
Interobserver reproducibility of ADNEXMR SCORING system using MRI with diffusion- and perfusion-weighted sequences by comparing lesion characterization (interpretation) and region of interest delineation on the perfusion curve.
Time frame: During estimated recruitment period of 2 years.
Accuracy of the suggested specific diagnosis made on the basis of the MRI images.
Time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Background: PubMed 22507534Woo YL, Kyrgiou M, Bryant A, Everett T, Dickinson HO. Centralisation of services for gynaecological cancers - a Cochrane systematic review. Gynecol Oncol. 2012 Aug;126(2):286-90. doi: 10.1016/j.ygyno.2012.04.012. Epub 2012 Apr 13.
- Background: PubMed 16369985Engelen MJ, Kos HE, Willemse PH, Aalders JG, de Vries EG, Schaapveld M, Otter R, van der Zee AG. Surgery by consultant gynecologic oncologists improves survival in patients with ovarian carcinoma. Cancer. 2006 Feb 1;106(3):589-98. doi: 10.1002/cncr.21616.
- Background: PubMed 18334710Vernooij F, Heintz AP, Witteveen PO, van der Heiden-van der Loo M, Coebergh JW, van der Graaf Y. Specialized care and survival of ovarian cancer patients in The Netherlands: nationwide cohort study. J Natl Cancer Inst. 2008 Mar 19;100(6):399-406. doi: 10.1093/jnci/djn033. Epub 2008 Mar 11.
- Background: PubMed 16449677Earle CC, Schrag D, Neville BA, Yabroff KR, Topor M, Fahey A, Trimble EL, Bodurka DC, Bristow RE, Carney M, Warren JL. Effect of surgeon specialty on processes of care and outcomes for ovarian cancer patients. J Natl Cancer Inst. 2006 Feb 1;98(3):172-80. doi: 10.1093/jnci/djj019.
- Background: PubMed 18504770Timmerman D, Testa AC, Bourne T, Ameye L, Jurkovic D, Van Holsbeke C, Paladini D, Van Calster B, Vergote I, Van Huffel S, Valentin L. Simple ultrasound-based rules for the diagnosis of ovarian cancer. Ultrasound Obstet Gynecol. 2008 Jun;31(6):681-90. doi: 10.1002/uog.5365.
- Background: PubMed 22095438Bernardin L, Dilks P, Liyanage S, Miquel ME, Sahdev A, Rockall A. Effectiveness of semi-quantitative multiphase dynamic contrast-enhanced MRI as a predictor of malignancy in complex adnexal masses: radiological and pathological correlation. Eur Radiol. 2012 Apr;22(4):880-90. doi: 10.1007/s00330-011-2331-z. Epub 2011 Nov 18.
- Background: PubMed 15955864Kinkel K, Lu Y, Mehdizade A, Pelte MF, Hricak H. Indeterminate ovarian mass at US: incremental value of second imaging test for characterization--meta-analysis and Bayesian analysis. Radiology. 2005 Jul;236(1):85-94. doi: 10.1148/radiol.2361041618. Epub 2005 Jun 13.
- Background: PubMed 23468574Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Darai E, Bazot M. Adnexal masses: development and preliminary validation of an MR imaging scoring system. Radiology. 2013 May;267(2):432-43. doi: 10.1148/radiol.13121161. Epub 2013 Mar 6.
- Background: PubMed 21193596Thomassin-Naggara I, Toussaint I, Perrot N, Rouzier R, Cuenod CA, Bazot M, Darai E. Characterization of complex adnexal masses: value of adding perfusion- and diffusion-weighted MR imaging to conventional MR imaging. Radiology. 2011 Mar;258(3):793-803. doi: 10.1148/radiol.10100751. Epub 2010 Dec 30.
- Background: PubMed 25600863Installe AJ, Van den Bosch T, De Moor B, Timmerman D. Clinical data miner: an electronic case report form system with integrated data preprocessing and machine-learning libraries supporting clinical diagnostic model research. JMIR Med Inform. 2014 Oct 20;2(2):e28. doi: 10.2196/medinform.3251.
- Background: PubMed 17161157Heintz AP, Odicino F, Maisonneuve P, Quinn MA, Benedet JL, Creasman WT, Ngan HY, Pecorelli S, Beller U. Carcinoma of the ovary. FIGO 26th Annual Report on the Results of Treatment in Gynecological Cancer. Int J Gynaecol Obstet. 2006 Nov;95 Suppl 1:S161-92. doi: 10.1016/S0020-7292(06)60033-7. No abstract available.
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
Department of Radiology, Hôpital Tenon, Paris, FRANCE
Andrea Rockall, MBBS, MRCP, FRCR study chair
Imperial College London, London, UNITED KINGDOM
Tom Bourne, MD, PhD study chair
Queen Charlotte's & Chelsea Hospital, Imperial College London, London, UNITED KINGDOM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diffusion/Perfusion-weighted Magnetic Resonance Imaging in people with Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules, run by KU Leuven at 1 site in Belgium.
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 7 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 14 Apr 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 Belgium. 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?
Contact Dirk Timmerman, MD, PhD (+32 16 344201, dirk.timmerman@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of the ADNEXMR SCORING system in classifying adnexal masses as malignant or benign using MRI with diffusion- and perfusion-weighted sequences in masses unclassified by the IOTA Simple Rules. (time frame: During estimated recruitment period of 2 years. Gold standard is histopathology diagnosis within 120 days after ultrasound examination.). 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 NCT02836275, which also lists 11 linked publications.
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 14 Apr 2020.