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Not yet recruiting NCT06157528

Diagnosis of Pelvic Endometriosis in MRI

No phase Interventional Endometriosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic resonance imaging.
Who it may be relevant to
Registry conditions: Endometriosis. Basic parameters: 16 years — 55 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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 test Magnetic resonance imaging
    Patients were treated with abarelix prior to the examination

Primary outcome measures

  • Measuring the number of lesions [Time frame: immediately after the surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06157528 · 1110000

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗