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Diagnosis of Pelvic Endometriosis in MRI

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06157528
Enrollment
100
Registered
2023-12-06
Start date
2023-12-20
Completion date
2029-12-31
Last updated
2023-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis

Brief summary

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.

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 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

Interventions

DIAGNOSTIC_TESTMagnetic resonance imaging

Patients were treated with abarelix prior to the examination

Sponsors

Zhenshen Ma
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
16 Years to 55 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Measuring the number of lesionsimmediately after the surgeryPre- 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.

Contacts

Primary ContactZhenshen Ma, PHD
mazhenshen@163.com+86 13789823607
Backup ContactYifan Xu, MD
948111149@qq.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026