Uterine Leiomyomas: MR Imaging–guided Focused Ultrasound Surgery—Results of Different Treatment Protocols¹

Abstract

MR imaging-guided focused ultrasound surgery results in symptomatic improvement, sustained to 12 months after treatment. Treatment with a modified protocol results in greater clinical effectiveness and fewer AEs.

Uterine Leiomyomas: MR Imaging–guided Focused Ultrasound Surgery—Imaging Predictors of Success

“…After screening, 135 patients were determined to meet all eligibility criteria and were treated with MR-guided focused ultrasound surgery at Brigham and Women's Hospital. The eligibility criteria for enrollment in the trial of MR-guided focused ultrasound surgery have been previously described (1)(2)(3)(4)(5). Patients with calcified fibroids were excluded.…”

“…Of the patients included in this study, 13 were from the pivotal trial population (4), 50 were from the continued access study (5), and three were part of a…”

“…The goal of this treatment is to cause thermal coagulation and ablation of the target fibroid by methodically sonicating multiple locations to reduce volume and provide symptom relief. Contrast agent-enhanced preand posttreatment MR images are used to determine the newly induced nonperfused volume (NPV) of the fibroid, which is the volume of tissue that was effectively ablated (5,(7)(8). Initial treatment guidelines were designed to provide safe treatment.…”

“…Initial treatment guidelines were designed to provide safe treatment. Treatments performed according to initial guidelines led to significant improvement in symptoms despite small volumes of tissue ablated and have been shown to be sustained 12 and 24 months after treatment in many patients (5,7). MR-guided focused ultrasound surgery has also been shown to be effective at fibroid volume reduction at 6-month follow-up (3).…”

“…Thus, it is important to examine the data and attempt to define criteria for treatment success. Fennessy et al (5) found that a patient's symptom score change at 6-month follow-up was partly determined by NPV after MR-guided focused ultrasound surgery: Treatment under more restrictive guidelines resulted in a smaller NPV and, thus, less symptom relief than that with the modified less restrictive guidelines. In another study, Funaki et al (9) reported a larger posttreatment NPV and, in line with this finding, greater volume reduction at 6-month follow-up in fibroids with low signal intensity (SI) on T2-weighted MR images.…”