Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids (PROMISe)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01377519
First received: June 15, 2011
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

This is a pilot randomized, blinded, placebo-controlled trial of a noninvasive, FDA approved treatment for uterine fibroids called MR Guided Focused Ultrasound (MRgFUS). Our hypothesis is that MRgFUS provides superior relief of fibroid symptoms compared with the placebo, a sham MRgFUS treatment. The investigators will recruit 20 premenopausal women with symptomatic uterine fibroids to participate in the trial. Participants will be randomly assigned in a 2:1 ratio to the active treatment arm (MRgFUS) versus the sham MRgFUS treatment. Participants will remain blinded to their group assignment for 3 months. After 3 months, participants will be told their treatment group and those assigned to the sham group will be offered complimentary MRgFUS if they desire it. Women will be excluded if they are inappropriate candidates for a 3 month delay in fibroid treatment, such as those with significant anemia. The investigators will assess the change from baseline to 1 and 3 months after treatment in fibroid symptoms, quality of life, fibroid volume measured by MRI, and hematocrit.


Condition Intervention
Uterine Fibroids
Procedure: MR Guided Focused Ultrasound
Procedure: Placebo MR Guided Focused Ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Fibroid volume measured on MRI [ Time Frame: Change from baseline prior to treatment until 3 months after treatment ] [ Designated as safety issue: No ]
  • Fibroid symptoms reported by participant [ Time Frame: Change from baseline prior to treatment to 1 and 3 months after treatment ] [ Designated as safety issue: No ]
  • Red blood cell count (hematocrit) [ Time Frame: Change from baseline prior to treatment and 3 months after treatment ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: June 2011
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MR Guided Focused Ultrasound Procedure: MR Guided Focused Ultrasound
This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
Placebo Comparator: Placebo MR Guided Focused Ultrasound Procedure: Placebo MR Guided Focused Ultrasound
This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age>18 years
  • Premenopausal
  • Symptomatic fibroids
  • Fibroids accessible for focused ultrasound treatment

Exclusion criteria:

  • Desires future fertility
  • Current pregnancy
  • Hematocrit <30%
  • Emergency room visit in last 3 months for fibroid symptoms
  • History of venous thromboembolism
  • Fibroids that are: >10cm, non-enhancing with contrast
  • Adenomyosis
  • Contraindications to undergoing MRI
  • Unexplained menstrual irregularity
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01377519

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Vanessa Jacoby, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01377519     History of Changes
Other Study ID Numbers: 001
Study First Received: June 15, 2011
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Fibroids
Uterine
Focused Ultrasound
Magnetic Resonance focused ultrasound
HIFU
NOninvasive
Treatment

Additional relevant MeSH terms:
Leiomyoma
Myofibroma
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on August 20, 2014