Status:
COMPLETED
MR Elastography Parameters Impact on MR-HIFU Efficacy in Uterine Fibroids
Lead Sponsor:
University Hospital, Bordeaux
Conditions:
Uterine Fibroid
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Magnetic resonance (MR)-guided high-intensity focused ultrasound (HIFU) ablation for fibroids is an outpatient approach for controlling symptom with an excellent safety record. It is important to excl...
Detailed Description
Pre-procedural predictors of treatment efficacy will be useful for excluding in advance patients who would not get benefit of this treatment. It seems that elastography, cellular density and perfusion...
Eligibility Criteria
Inclusion
- Woman
- Aged more than 18 years
- Not postmenopausal
- Having one or two symptomatic fibroid with size \< 15cm.
- Leiomyoma type Funaki 1 or 2 on pre-therapeutic MRI
- Normal cervicovaginal smear performed within 2 years prior to inclusion
- Myoma technically accessible to MR-HIFU treatment verified on pre-therapeutic MRI
- SSS score on UFS-Qol ≥ 10
- Signed informed consent prior to any study related procedure
- With a medical insurance
Exclusion
- Contraindicated to MR examination, gadolinium contrast injection (pregnancy etc..).
- Presence or suspicious of pelvic malignant tumor
- Myomas causing haemorrhage (meno-metrorrhagia) associated with anemia (Hb \<10g/dl)
- Pregnant or lactating woman
- Small submucous myoma accessible for hysteroscopic treatment.
- Active pelvic infection
- Presence of calcification, surgical staples, or rigid implant in the passage of the ultrasound beamo People placed under legal protection, or participating in another research protocol including an exclusion period still in progress at pre-inclusion.
Key Trial Info
Start Date :
June 18 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04345003
Start Date
June 18 2020
End Date
August 31 2023
Last Update
December 7 2023
Active Locations (1)
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1
CHU Bordeaux
Bordeaux, France