Skip to content

Diffusion MRI (Magnetic Resonance Imaging) Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness

Diffusion Magnetic Resonance Imaging Using ADC (Apparent Diffusion Coefficient) Histograms in the Evaluation of Adnexal Tumor Aggressiveness

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02742870
Enrollment
126
Registered
2016-04-19
Start date
2016-03-08
Completion date
2019-01-30
Last updated
2020-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adnexal Tumor

Keywords

Diffusion MRI, ADC histograms, Adnexal tumor

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.

Interventions

OTHERCorrelation of MRI results with clinical characteristics of the adnexal mass

Quantitative analysis of the magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens), based on the ADC cartography.The post-processing will be realized with the Syngo Onco Care application of Siemens, that allows an histogram analysis of the ADC of all sections of the adnexal mass, as opposed to a section per section approach with the Region of Interest (ROI) method. The results will be correlated with the clinical data regarding the adnexal mass: anatomo-pathology status (malignancy and aggressiveness of the tumor) and the gynecological follow-up.

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)From 01/01/2015 till the end of study (2 years)Apparent diffusion coefficient (ADC) expressed in mm2/sec. Magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens).Post-processing realized with the Syngo Onco Care application of Siemens.
Anatomo-pathology classification - histological typeFrom 01/01/2015 till the end of study (2 years)Follow-up of the patients that did undergo surgery: histological type of tumor. The histological type of the tumor will be determined by the Anatomo-Pathology Department of the CHU Brugmann hospital, according to standard of care.
MRI Adnex scoreFrom 01/01/2015 till the end of study (2 years)Follow-up of the patients that did not undergo surgery: medical imaging classification of the adnexal mass (MRI Adnex score)
IOTA ultrasound classificationFrom 01/01/2015 till the end of study (2 years)Follow-up of the patients that did not undergo surgery: transvaginal ultrasound classification of the adnexal masse (IOTA ultrasound classification)
Anatomo-pathology classification - malignancy grading of tumorFrom 01/01/2015 till the end of study (2 years)Follow-up of the patients that did undergo surgery: malignancy grading of the adnexal mass according to FIGO classification.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026