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临床试验/NCT06157528
NCT06157528尚未招募不适用

Diagnosis of Pelvic Endometriosis: a Preliminary Study on the Added Value of R2*MFGRE Sequence in MRI

Zhenshen Ma0 个研究点目标入组 100 人开始时间: 2023年12月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
100
主要终点
Measuring the number of lesions

研究概览

简要总结

Purpose: Evaluate the feasibility of R2 star multiple fast gradient recalled echo (R2*MFGRE) imaging in the diagnosis of pelvic endometriosis.

One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2*MFGRE imaging. Clinical diagnosis was pathologically confirmed one month after MRI examination. Three radiologists who were blinded to the pathological results evaluated the numbers of ovarian endometriomas (OMAs) and deep in-filtrating endometriosis (DIE) lesions using routine MRI and its combination with R2*MFGRE. MRI changes of lesion size before and after estrogen therapy.

详细描述

This prospective study was approved by the Ethics Committee of the local hos-pital, and informed consent was obtained from all the patients in this study (3701027061515). All procedures performed in studies involving human participants were in accordance with the ethical standards of our institutional and national re-search committee and with the Declaration of Helsinki.

Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2*MFGRE imaging from Decemberr 2017 to December 2023. Of those, One hundred and forty patients were submitted to surgical (either laparotomy or laparoscopy) treatment for endometriosis. The diagnosis was confirmed by pathology within one month after the initial MR exam. Additionally, 20 out of 160 patients were excluded from the study. Of these, 11 were due to non-surgical treatment, and the other 8 were due to prominent susceptibility artifacts caused by colonic overdistention, limiting the vis-ibility of the pelvis. Finally, One hundred patients were included in the study.

All 100 patients were aged ranging from 24 to 54 years, with an average age of 37.8 years. Their clinical symptoms included dysmenorrhea, bulging in the lower abdomen or anus, heavy menstrual bleeding, dyspareunia, and infertility. Some of these patients had multiple symptoms

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
16 Years 至 55 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

  • patients who proven endometriosis by pathology Patients who wish to be treated

排除标准

  • Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts

结局指标

主要结局

Measuring the number of lesions

时间窗: immediately after the surgery

Pre- surgery, the number of lesions was counted during Magnetic resonance imaging by radiologists. Immediately after the intervention, the number of lesions found during the operation was counted by the surgeon.

次要结局

未报告次要终点

研究者

发起方
Zhenshen Ma
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Zhenshen Ma

Professor

Qianfoshan Hospital

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