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Completed

NCT Number: NCT01377519

Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

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.

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Key information

Conditions

Uterine Fibroids Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue

Age range

18 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of California, San Francisco

San Francisco, California, 94115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MR Guided Focused Ultrasound

Procedure

This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.

Placebo MR Guided Focused Ultrasound

Procedure

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.

Primary outcomes

  1. Fibroid volume measured on MRI

    Time frame: Change from baseline prior to treatment until 3 months after treatment

  2. Fibroid symptoms reported by participant

    Time frame: Change from baseline prior to treatment to 1 and 3 months after treatment

  3. Red blood cell count (hematocrit)

    Time frame: Change from baseline prior to treatment and 3 months after treatment

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial

Acronym: PROMISe

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 21, 2011
Registry last updated
Nov 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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