An interventional study of Magnetic resonance imaging in Endometriosis, sponsored by Zhenshen Ma. Not yet recruiting. Open to female participants aged 16 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-06.
Sponsored by Zhenshen Ma · Not applicable, Interventional, and Diagnostic
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.
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
925 studies on the registry are indexed under Endometriosis; 264 are open to participants now.
This study's planned enrollment of 100 is above the median of 65 across 539 interventional studies indexed under Endometriosis.
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Exclusion Criteria:
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
Diagnostic Test: Magnetic resonance imaging
Patients were treated with abarelix prior to the examination
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.
Time frame: immediately after the surgery
No study locations are listed for this record.
Start is estimated for Dec 2023; primary completion for Nov 2028, 59 months later.
Of 193 non-industry interventional studies with no phase under Endometriosis, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 44. This study's planned 59 months is above that.
Counting every sponsor, half of 208 studies reached it within 25 months; a quarter within 13 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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