Clinical trial NCT02742870: Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
Official title: Diffusion Magnetic Resonance Imaging Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adnexal Tumor
Keywords: Diffusion MRI
ADC histograms
Adnexal tumor
Lead sponsor: Brugmann University Hospital
Sponsor class: OTHER
First posted: 2016-04-19
Enrollment: 126
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.

Brief summary: Diffusion-weighted sequences have been routinely performed for years to study the pelvis. They have been so far mainly qualitatively interpreted, that is to say as the absence or presence of an hypersignal at a high b value. The quantitative analysis involves placing the region of interest (ROI) on the apparent diffusion coefficient (ADC) map. The manual placement is very operator dependent, and does not reflect the entirety of the studied mass.

In all fields of Magnetic Resonance Imaging, a multiparametric approach integrating diffusion analysis is flourishing. However, the quantitative analysis of the diffusion is still little studied for tumor heterogeneity analysis, including in the gynecological sphere.

The investigators will therefore retrospectively evaluate the apparent diffusion coefficient (ADC) histograms, extracted from the diffusion ponderation sequences, of the magnetic imaging resonance analysis of adnexal masses and confront the results with the anatomo-pathology results, for patients having undergone surgery, and/or with the clinical and imagery follow-up results.

The investigators goal will be to improve the performance of conventional MRI in the analysis of adnexal masses.

The expected benefits of this study are:

* a correlation with the histology analysis or the clinical monitoring
* an improved prediction of the malignancy of the tumor
* an improved magnetic resonance imaging performance for adnexal masses, with better surgical therapeutic management
* an improved negative predictive value, thereby ultimately limiting unnecessary surgical explorations.


Eligibility criteria: Inclusion Criteria:

- Women aged over 18 years old, having undergone magnetic resonance imaging of the pelvis within the CHU Brugmann hospital.

Exclusion Criteria:

* Examinations without diffusion sequences
* Examinations with incomplete diffusion sequences
* Absence of anato-pathologic result, or absence of gynecological clinical/imaging follow-up.

Primary outcomes:
measure: Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)
timeFrame: From 01/01/2015 till the end of study (2 years)
measure: Anatomo-pathology classification - histological type
timeFrame: From 01/01/2015 till the end of study (2 years)
measure: MRI Adnex score
timeFrame: From 01/01/2015 till the end of study (2 years)
measure: IOTA ultrasound classification
timeFrame: From 01/01/2015 till the end of study (2 years)
measure: Anatomo-pathology classification - malignancy grading of tumor
timeFrame: From 01/01/2015 till the end of study (2 years)
Secondary outcomes:
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: CHU Brugmann
Study officials:
affiliation: CHU Brugmann
name: Mieke Cannie, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Brugmann
name: Nathalie Hottat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thomassin-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.
citation: Just N. Improving tumour heterogeneity MRI assessment with histograms. Br J Cancer. 2014 Dec 9;111(12):2205-13. doi: 10.1038/bjc.2014.512. Epub 2014 Sep 30.