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Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future

Primary Purpose

Uterine Fibroids, Pregnancy

Status
Withdrawn
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Magnetic Resonance Guided Focused Ultrasound
Sponsored by
Imperial College London
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Fibroids focused on measuring MR guided FUS, Uterine Fibroids, Fertility, Pregnancy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation. If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test. Women undergoing fertility treatment or plan to have sperm donation. 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period. 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site. 4. Able and willing to give consent and able to attend all study visits 5. Able to communicate sensations during the MRgFUS procedure 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). 7. Tumor(s) are clearly visible on non-contrast MRI. 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH Exclusion Criteria: 1. Patient is pregnant as confirmed by pregnancy test at time of screening 2. Uterine size >20 weeks as evaluated by US or MR. 3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids. 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable 5. Patients with adenomyosis 6. Patient is on dialysis 7. Hematocrit is < 25 8. Patient has hemolytic anemia 9. Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence of cardiac pacemaker 10. Patient has an ASA score of >2 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months) 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder 13. Evidence of uterine pathology other than leiomyoma 14. Patient has an active pelvic infection or history of pelvic inflammatory disease 15. Patient has an undiagnosed pelvic mass outside the uterus. 16. Patient weight >110 kg 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area. 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices. 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist). 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.) 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path. 22. Women who are breast feeding. 23. Five or more fibroids, bigger then 3cm diameter, each

Sites / Locations

  • St Mary's Hospital

Outcomes

Primary Outcome Measures

Pregnancy outcomes in women who have received treatment with MRgFUS

Secondary Outcome Measures

Efficacy of MRgFUS as judged by HRQOL questionnaires

Full Information

First Posted
September 13, 2005
Last Updated
October 20, 2023
Sponsor
Imperial College London
Collaborators
InSightec
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1. Study Identification

Unique Protocol Identification Number
NCT00180739
Brief Title
Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future
Official Title
Magnetic Resonance Guided Focused Ultrasound Surgery in the Treatment of Uterine Fibroids in Women Desiring Future Pregnancies
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Recruitment not possible worldwide
Study Start Date
April 2004 (Actual)
Primary Completion Date
August 2005 (Actual)
Study Completion Date
August 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
InSightec

4. Oversight

5. Study Description

Brief Summary
The study objective is to develop data for the safety of pregnancies after thermal ablation of uterine fibroids by MR guided Focused Ultrasound using the Ex Ablate 2000 system.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Fibroids, Pregnancy
Keywords
MR guided FUS, Uterine Fibroids, Fertility, Pregnancy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Magnetic Resonance Guided Focused Ultrasound
Primary Outcome Measure Information:
Title
Pregnancy outcomes in women who have received treatment with MRgFUS
Secondary Outcome Measure Information:
Title
Efficacy of MRgFUS as judged by HRQOL questionnaires

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 1. Subject with uterine fibroids, who desire pregnancy within 12 months and has the one of the following criteria: Women 20-40 age. Women age < 46 years old who plan to have egg donation. Women above 38 should test for normal ovarian function as judged by endocrinological evaluation. If the couple has failed to conceive for more that 1 year, the woman should test for normal ovarian function as judged by endocrinological evaluation, and the male must have adequate sperm test. Women undergoing fertility treatment or plan to have sperm donation. 2. Use or non use of non-steroidal treatments for excessive vaginal bleeding such as antifibrinolytic agents (e.g. Tranexamic acid) or non-steroidal anti-inflammatory drugs (e.g. Mefanamic Acid) has been maintained for the three months prior to the planned date of the study procedure and the patient has agreed to maintain this use or non-use through the 6-month follow-up period. 3. Clinically normal PAP smear within timing of National Guidelines in the country of the clinical site. 4. Able and willing to give consent and able to attend all study visits 5. Able to communicate sensations during the MRgFUS procedure 6. Having uterine fibroids that are device accessible (i.e., positioned in the uterus such that they can be accessed without being shielded by bowel or bone). 7. Tumor(s) are clearly visible on non-contrast MRI. 8. Largest fibroid 8 cm in diameter or 12 cm if receiving GnRH Exclusion Criteria: 1. Patient is pregnant as confirmed by pregnancy test at time of screening 2. Uterine size >20 weeks as evaluated by US or MR. 3. Patients who are considered "high risk pregnancy" due to uterine factors (e.g. abnormal uterus, uterine scars, cerclage) except fibroids. 4. Patients with fibroid that is more than 50% sub-mucosal or with hysteroscopically resectable 5. Patients with adenomyosis 6. Patient is on dialysis 7. Hematocrit is < 25 8. Patient has hemolytic anemia 9. Patient has unstable cardiac status including: § Unstable angina pectoris on medication§ Documented myocardial infarction within 6 months of protocol entry§ Congestive heart failure requiring medication (other than diuretic)§ Currently taking anti-arrhythmic drugs§ Severe hypertension (diastolic BP>100 on medication)§ Presence of cardiac pacemaker 10. Patient has an ASA score of >2 11. Patient has severe cerebrovascular disease (multiple CVA or CVA within 6 months) 12. Patient is on anti-coagulation therapy or has an underlying bleeding disorder 13. Evidence of uterine pathology other than leiomyoma 14. Patient has an active pelvic infection or history of pelvic inflammatory disease 15. Patient has an undiagnosed pelvic mass outside the uterus. 16. Patient weight >110 kg 17. Subject with extensive abdominal scarring in an area of the abdomen directly anterior to the treatment area. 18. Subject with standard contraindications for MR imaging such as non-MRI compatable implanted metallic devices. 19. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist). 20. Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hours.) 21. Patient with an intrauterine contraceptive device anywhere in the treatment beam path. 22. Women who are breast feeding. 23. Five or more fibroids, bigger then 3cm diameter, each
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wady Gedroyc
Organizational Affiliation
St Mary's NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15547216
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. Erratum In: AJR Am J Roentgenol. 2005 Jan;184(1):348. Hynnen, Kullvro [corrected to Hynyen, Kullervo]; Macdanold, Nathan [corrected to Mcdannold, Nathan]; Kim, Kevin [corrected to Kim, Hyun S]; Gostout, Brian [corrected to Gostout, Bobbie].
Results Reference
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Safety Trial of Magnetic Resonance (MR) Guided Focused Ultrasound Surgery (FUS) in Women With Uterine Fibroids Wishing to Pursue Pregnancy in the Future

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