Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids

Imperial College London50 enrolled

Overview

The purpose of this study is to determine whether ablation of uterine fibroids with MR guided focused ultrasound following 3 months pre-treatment with Gonadotrophin releasing analogues will allow the effective use of this therapy in women with larger fibroids.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Uterine Fibroids

Interventions

Magnetic Resonance Guided Focused UltrasoundPROCEDURE

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subject has given consent * Willing and able to attend all visits * Minimum age 18 with no desire for future fertility * Uterine fibroid \> 300 cc on MRI * Normal cervical smear * Screening symptom score \>21 * Pre or peri-menopausal * Fibroids being device accessible Exclusion Criteria: * Pregnancy * Previous GNRH treatment * HRT use * Hormonal Contraception * Patient on dialysis * Haematocrit \<25 * ASA score \> 2 * Severe cerebrovascular disease * Anticoagulated * Active pelvic infection or history of PID * Weight\> 250 lbs * Any contra-indication to MR imaging * Intolerance to MRI contrast agent * Unable to remain in prone positions for 3hours * IUCD * Abdominal scarring in beam pathway * Breast feeding * Non-perfused fibroid on contrast enhanced images

Locations (1)

Department of Interventional Magnetic Resonance, St Mary's Hospital

London, United Kingdom

Outcomes

Primary Outcomes

Symptom improvement as judged by validated disease specific questionnaire

Secondary Outcomes

Change in fibroid and uterine volume.

Data from ClinicalTrials.gov

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