Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06157528
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-12-06
First Post:
2023-11-02
Brief Title:
Diagnosis of Pelvic Endometriosis in MRI
Sponsor:
Zhenshen Ma
Organization:
Qianfoshan Hospital
Study Overview
Official Title:
Diagnosis of Pelvic Endometriosis a Preliminary Study on the Added Value of R2MFGRE Sequence in MRI
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Purpose Evaluate the feasibility of R2 star multiple fast gradient recalled echo R2MFGRE imaging in the diagnosis of pelvic endometriosis
One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2MFGRE 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 R2MFGRE MRI changes of lesion size before and after estrogen therapy
One hundred patients with suspected endometriosis underwent routine pelvic MRI and R2MFGRE 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 R2MFGRE MRI changes of lesion size before and after estrogen therapy
Detailed Description:
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 R2MFGRE 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 378 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
Study population One hundred and Sixty-five patients with suspected endometriosis underwent pelvic MRI with R2MFGRE 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 378 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None