Diagnosis of Pelvic Endometriosis in MRI

Endometriosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06157528
• Other study ID #: 1110000
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 2029

Study information

• Verified date: December 2023
• Source: Qianfoshan Hospital
• Contact: Zhenshen Ma, PHD
• Phone: +86 13789823607
• Email: mazhenshen[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: December 2029
• Est. primary completion date: November 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometriosis

Intervention

Diagnostic Test:
• Magnetic resonance imaging
Patients were treated with abarelix prior to the examination

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zhenshen Ma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring the number of lesions	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.	immediately after the surgery