Fusion Ultrasound for Diagnosis and Monitoring of Endometriosis Lesions ENDOFUSION
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, positive predictive value (VPP) and negative predictive value (VPN) of fusion ultrasound compared to transvaginal ultrasound and MRI for the diagnosis of endometriosis lesions
研究概览
简要总结
The aim of the study is evaluate the fusion ultrasound performance compared to MRI and coelioscopy diagnosis when a surgical intervention is performed.
详细描述
The research is about diagnosis performance between fusion ultrasound and the gold standard (MRI coelioscopy ). Fusion ultrasound is a no-invasive scientific technical which allow with security to evaluate the progress of endometriosis lesions. During 39 months, 200 patients will be follow. In one arm, there is the control group with women without endometriosis. In the second arm, there is the patient with endometriosis. We will compare monitoring differences between gold standard and fusion ultrasound ( Cost assessment,exams duration, reproductibility, the link between symptoms and evolution of the lesion size).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients from 18 to 50 years old
- •Patient informed and who gave her non-opposition to participate in the research
- •Patient with an indication for pelvic MRI and pelvic ultrasound either for the exploration of endometriosis or pelvic pain, or for another gynaecological pathology (ovarian cyst, poly-myomatous uterus, uterine malformation) outside of a proven cancer indication.
- •Patient affiliated to a social security or entitled to a social security allowance
排除标准
- •Patient with a proven cancerous pathology at the time of the prescription of the complementary examinations.
- •Virgin patient
- •Pregnant patient
- •Patients under protective measures
- •Contraindication to MRI (claustrophobia, intracorporeal metallic foreign body)
结局指标
主要结局
Sensitivity, specificity, positive predictive value (VPP) and negative predictive value (VPN) of fusion ultrasound compared to transvaginal ultrasound and MRI for the diagnosis of endometriosis lesions
时间窗: 3 years and 3 months
To evaluate the diagnostic performance of fusion ultrasound compared to transvaginal gynaecological ultrasound and MRI for the diagnosis of endometriosis lesions.
次要结局
- Compare the duration of a standard ultrasound scan to an ultrasound scan with fusion(3 years and 3 months)
- Evaluate the reproducibility of the conclusions of the fusion ultrasound between 2 operators.(3 years and 3 months)
- Evaluation of the cost of imaging for 3 years between an annual fusion ultrasound surveillance in replacement of a annual MRI surveillance(3 years and 3 months)
- To evaluate the contribution of fusion ultrasound in the follow-up of patients suffering from endometriosis, in particular with an ultrasound follow-up in comparison with an initial reference MRI in the case of medical or surgical management.(3 years and 3 months)