Clinical trial · Interventional
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids
Magnetic Resonance-Guided Focused Ultrasound to Treat Uterine Fibroids: A Pilot Randomized, Placebo-Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Uterine Fibroids | Uterine Corpus Leiomyoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR Guided Focused Ultrasound | Procedure | — | UNRESOLVED |
| Placebo MR Guided Focused Ultrasound | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MR Guided Focused Ultrasound
- interventionNames
- Procedure: MR Guided Focused Ultrasound
- type
- PLACEBO_COMPARATOR
- label
- Placebo MR Guided Focused Ultrasound
- interventionNames
- Procedure: Placebo MR Guided Focused Ultrasound
Primary outcomes (3)
- measure
- Fibroid volume measured on MRI
- timeFrame
- Change from baseline prior to treatment until 3 months after treatment
- measure
- Fibroid symptoms reported by participant
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJacoby 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