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

Adnexal Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02742870
• Other study ID #: CHUB-MRI-Adnexal Tumor
• Status: Completed
• Start date: March 8, 2016
• Est. completion date: January 30, 2019

Study information

• Verified date: January 2020
• Source: Brugmann University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Adnexal Tumor
• Aggression

Intervention

Other:
• Correlation 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.

Locations

Country	Name	City	State
Belgium	CHU Brugmann	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Brugmann University Hospital

Country where clinical trial is conducted

Belgium, 

References & Publications (2)

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. Review. — View Citation

Thomassin-Naggara I, Aubert E, Rockall A, Jalaguier-Coudray A, Rouzier R, Daraï 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)	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.	From 01/01/2015 till the end of study (2 years)
Primary	Anatomo-pathology classification - histological type	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.	From 01/01/2015 till the end of study (2 years)
Primary	MRI Adnex score	Follow-up of the patients that did not undergo surgery: medical imaging classification of the adnexal mass (MRI Adnex score)	From 01/01/2015 till the end of study (2 years)
Primary	IOTA ultrasound classification	Follow-up of the patients that did not undergo surgery: transvaginal ultrasound classification of the adnexal masse (IOTA ultrasound classification)	From 01/01/2015 till the end of study (2 years)
Primary	Anatomo-pathology classification - malignancy grading of tumor	Follow-up of the patients that did undergo surgery: malignancy grading of the adnexal mass according to FIGO classification.	From 01/01/2015 till the end of study (2 years)