Patients With a Sonographically Unclassifiable Adnexal Mass Using the IOTA Simple Rules Clinical Trial
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.
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.
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.
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