Clinical trial NCT00159328: Efficacy Study of Magnetic Resonance (MR) Guided Focused Ultrasound in the Treatment of Large Fibroids
Official title: Phase 4 Study of Magnetic Resonance Guided Focused Ultrasound Surgery Following Gonadotrophin Releasing Hormone Agonist Treatment for Symptomatic Uterine Fibroids
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Uterine Fibroids
Keywords: Magnetic Resonance Guided Focused Ultrasound
Gonadotrophin Releasing Hormone Agonist
Uterine Fibroids
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: InSightec-TxSonics
First posted: 2005-09-12
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Symptom improvement as judged by validated disease specific questionnaire
Secondary outcomes:
measure: Change in fibroid and uterine volume.
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Department of Interventional Magnetic Resonance, St Mary's Hospital
Study officials:
affiliation: St Mary's Hospital, Imperial College London.
name: wady m gedroyc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hindley J, Gedroyc WM, Regan L, Stewart E, Tempany C, Hynyen K, Mcdannold N, Inbar Y, Itzchak Y, Rabinovici J, Kim HS, Geschwind JF, Hesley G, Gostout B, Ehrenstein T, Hengst S, Sklair-Levy M, Shushan A, Jolesz F. MRI guidance of focused ultrasound therapy of uterine fibroids: early results. AJR Am J Roentgenol. 2004 Dec;183(6):1713-9. doi: 10.2214/ajr.183.6.01831713.
citation: Stewart EA, Gedroyc WM, Tempany CM, Quade BJ, Inbar Y, Ehrenstein T, Shushan A, Hindley JT, Goldin RD, David M, Sklair M, Rabinovici J. Focused ultrasound treatment of uterine fibroid tumors: safety and feasibility of a noninvasive thermoablative technique. Am J Obstet Gynecol. 2003 Jul;189(1):48-54. doi: 10.1067/mob.2003.345.
citation: Tempany CM, Stewart EA, McDannold N, Quade BJ, Jolesz FA, Hynynen K. MR imaging-guided focused ultrasound surgery of uterine leiomyomas: a feasibility study. Radiology. 2003 Mar;226(3):897-905. doi: 10.1148/radiol.2271020395.