跳至主要内容
临床试验/NCT02742870
NCT02742870已完成不适用

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

Brugmann University Hospital1 个研究点 分布在 1 个国家目标入组 126 人开始时间: 2016年3月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
126
试验地点
1
主要终点
MRI Adnex score

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

MRI Adnex score

时间窗: From 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 classification

时间窗: From 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)

Apparent diffusion coefficient (ADC) of the adnexal mass volume (mm2/sec)

时间窗: 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 type

时间窗: From 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.

Anatomo-pathology classification - malignancy grading of tumor

时间窗: From 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mieke Cannie

Head of clinic

Brugmann University Hospital

研究点 (1)

Loading locations...

相似试验