- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06481982
Value of Advanced MRI Techniques in the Assessment of Endometriosis
Endometriosis is a common gynaecological disease, mostly in women of reproductive age, with a prevalence of about 10 %, which is defined by the presence of endometrial-type tissue outside the uterine cavity. Endometriosis is usually limited to the abdominal and especially the pelvic cavity, extra-abdominal lesions are rare. Within the pelvis it shows a wide variety of locations predominantly affecting the ovaries and the uterus or the peritoneum, uterine ligaments and other pelvic structures. Traditionally, there are three major phenotypes of endometriosis: Ovarian endometrioma (OMA), superficial peritoneal endometriosis (SPE), and deep infiltrating endometriosis (DIE). A lesion is considered a DIE, if it shows infiltration deeper than 5 mm into the peritoneum. The ectopic endometrial implants may induce inflammatory processes, causing scar tissue formation, adhesions, and consequently pelvic anatomy distortion.
The prospective study aims to investigate the value of advanced MRI techniques to improve the assessment of pelvic endometriosis.
Study Overview
Study Type
Contacts and Locations
Study Locations
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Canton of Zurich
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Zurich, Canton of Zurich, Switzerland, 8091
- University Hospital Zurich
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients who undergo clinically indicated MR imaging for endometriosis evaluation.
Exclusion Criteria:
- Non-MRI compatible devices/implants
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Diagnostic Accuracy
Time Frame: 5 years
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Diagnostic accuracy of different MRI sequences in comparison to ultrasound assessment and/or laparoscopy as standard of reference.
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5 years
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Advanced MRI Endometriosis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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