Diagnosis of Pelvic Endometriosis in MRI
1 other identifier
interventional
100
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2023
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
December 6, 2023
CompletedStudy Start
First participant enrolled
December 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2029
December 6, 2023
December 1, 2023
4.9 years
November 2, 2023
December 3, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
ovarian endometriomas
EXPERIMENTALPatients 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
Interventions
Patients were treated with abarelix prior to the examination
Eligibility Criteria
You may qualify if:
- patients who proven endometriosis by pathology Patients who wish to be treated
You may not qualify if:
- Received any treatment (radiotherapy, chemotherapy, surgery or chemoradiotherapy) before undergoing imaging studies poor-quality MR images with any severe motion or artifacts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zhenshen Malead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 2, 2023
First Posted
December 6, 2023
Study Start
December 20, 2023
Primary Completion (Estimated)
November 1, 2028
Study Completion (Estimated)
December 1, 2029
Last Updated
December 6, 2023
Record last verified: 2023-12