Diagnosis of Pelvic Endometriosis in MRI

NCT ID: NCT06157528

Last Updated: 2023-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2029-12-31

Brief Summary

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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

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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

Conditions

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Endometriosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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ovarian endometriomas

Patients received a single dose of 1OOmg abarelix injection with slow absorption, Cmax of (43.4±32.3)ng/mL, Tmax of (3.0±2.9) days. AUC0-∞ is (500 ±96) ng·d/mL, t1/2 is (13.2±3.2) days, CL/F is (208±48) L/d

Group Type EXPERIMENTAL

Magnetic resonance imaging

Intervention Type DIAGNOSTIC_TEST

Patients were treated with abarelix prior to the examination

Interventions

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Magnetic resonance imaging

Patients were treated with abarelix prior to the examination

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Zhenshen Ma

OTHER

Sponsor Role lead

Responsible Party

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Zhenshen Ma

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Central Contacts

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Zhenshen Ma, PHD

Role: CONTACT

Phone: +86 13789823607

Email: [email protected]

Yifan Xu, MD

Role: CONTACT

Email: [email protected]

Other Identifiers

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1110000

Identifier Type: -

Identifier Source: org_study_id