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NCT Number: NCT06157528

Diagnosis of Pelvic Endometriosis in MRI

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.

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Key information

Age range

16 year–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Magnetic Resonance Imaging

Diagnostic Test

Patients were treated with abarelix prior to the examination

Primary outcomes

  1. Measuring the number of lesions

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yifan Xu, MD

CONTACT

[email protected]

Zhenshen Ma, PHD

CONTACT

[email protected]

+86 13789823607

Sponsors and collaborators

Lead sponsor

Zhenshen Ma

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Dec 6, 2023
Registry last updated
Dec 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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