Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

NCT01377519 | Completed DMC

• 1 other identifier: 001
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Uterine Fibroids

Keywords

Fibroids; Uterine; Focused Ultrasound; Magnetic Resonance focused ultrasound; HIFU; NOninvasive; Treatment

Outcome Measures

Primary Outcomes (3)

• Fibroid volume measured on MRI

  Change from baseline prior to treatment until 3 months after treatment

• Fibroid symptoms reported by participant

  Change from baseline prior to treatment to 1 and 3 months after treatment

• Red blood cell count (hematocrit)

  Change from baseline prior to treatment and 3 months after treatment

Study Arms (2)

MR Guided Focused Ultrasound

ACTIVE COMPARATOR

Procedure: MR Guided Focused Ultrasound

Placebo MR Guided Focused Ultrasound

PLACEBO COMPARATOR

Procedure: Placebo MR Guided Focused Ultrasound

Interventions

MR Guided Focused Ultrasound PROCEDURE

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

MR Guided Focused Ultrasound

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.

Placebo MR Guided Focused Ultrasound

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Related Publications (1)

• Jacoby VL, Kohi MP, Poder L, Jacoby A, Lager J, Schembri M, Rieke V, Grady D, Vittinghoff E, Coakley FV. PROMISe trial: a pilot, randomized, placebo-controlled trial of magnetic resonance guided focused ultrasound for uterine fibroids. Fertil Steril. 2016 Mar;105(3):773-780. doi: 10.1016/j.fertnstert.2015.11.014. Epub 2015 Dec 1.

  PMID: 26658133 DERIVED

Related Links

• Fibroid trials at UCSF

MeSH Terms

Conditions

Leiomyoma

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Vanessa Jacoby, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2011
• First Posted: June 21, 2011
• Study Start: June 1, 2011
• Primary Completion: September 1, 2012
• Study Completion: December 1, 2012
• Last Updated: November 5, 2019

Record last verified: 2019-11

Locations

US (1)