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

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.

Placebo MR Guided Focused Ultrasound

Vanessa Jacoby, MD

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.

Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids

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

University of California, San Francisco

Head and Neck Neoplasms

Two treatments of focused ultrasound under MRI guidance

Irene Karam, MD

Head and neck cancer is the sixth most common form of malignancy world-wide. Surgery, chemotherapy and radiation are associated with a high burden of side effects; tumour recurrence within the neck continues to be a major cause of treatment failure. To our knowledge, this research is the first clinical study in human subjects to utilize magnetic resonance guided focused ultrasound to treat cancer of the neck. The goal is to evaluate the safety and technical feasibility of this therapy in order to guide future clinical applications such as ablation, radiosensitization or drug delivery that could ultimately improve clinical outcomes. A total of 10 patients will be treated with MR guided focused ultrasound.

This is a single institution, prospective pilot study to evaluate the safety and feasibility of MR guided focused ultrasound treatment for cancer of the neck in 10 patients. The procedure will consist of a planning MRI scan and two treatment sessions where real time MRI thermometry is used in conjunction with a focused beam to heat the tissue to 40-42oC in the target field over a period of 20-30 seconds per treatment. All patients on the study will undergo palliative radiotherapy and/or chemotherapy. MRg-FU treatments will be delivered on fraction #1 and fraction #10 (50 Gy/20 regimen) or on fraction #1 and fraction #3 (35-45 Gy/5 SBRT regimen). Palliative radiotherapy treatment will be administered to the treatment target lesion and in addition may encompass other tumour regions of the head and neck. The prescribed dose for patients who have not received previous radiotherapy will be between 50Gy over 4 weeks using IMRT or VMAT -based planning or 35-45 Gy in 5 fractions using SBRT technique; in previously irradiated patients, the dose will be determined at the discretion of the treating radiation oncologist. The patient will be assessed by a physician investigator and clinical research assistant (CRA) on the MRg-FU treatment dates, then 1 day, 1 week, 2 weeks, 1 month and 3 months afterward.

MRG FU With Radiotherapy for Palliation of H&N Cancer

Magnetic Resonance-Guided Focused Ultrasound Combined With Radiotherapy for Palliation of Head and Neck Cancer - A Pilot Study

The number, type and severity of adverse effects as assessed using NCI CTCAE v4.03.

The number of patients that meet the eligibility criteria and are able to complete the study treatment protocol.

Assessment of changes caused by MR guided FU within the treated tumour region based on post treatment MRI

Focused Ultrasound Foundation

Sunnybrook Health Sciences Centre

Radiation Oncologist

Symptoms and General Pathology

Behaviors and Mental Disorders

Hemorrhage

Pain

Quality of Life

Exablate 2100

The first magnetic resonance-guided focused ultrasound (MRgFUS) treatment of uterine fibroid using the ExAblate 2000 system was performed in 2001. Since then, more than 5000 treatments were done in more than 60 different hospitals around the world. The experience accumulated in this novel treatment was collected by InSightec and implemented into software and hardware updates, clinical tips and guidelines, all aimed to improve the clinical results and their durability, while maintaining a high level of safety.

Based on extensive clinical experience and our internal research and development effort goals toward continuous improvement in ExAblate treatment safety and performance, limited changes have been made to the current ExAblate system. This modified ExAblate system version is designated as the ExAblate 2100 UF V2 system.

The modifications are believed to improve system's friendliness to the user, without introducing new risks or other issues of safety of the device, and should not have any negative impact on the safety or technical efficacy of the treatments for patients.

A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids

Safety of ExAblate 2100 UF V2 will be determined by an evaluation of the incidence and severity of device- and procedure-related adverse events from the first visit through 1-month post-treatment.

Efficacy will be evaluated by comparing the Non-perfused volume obtained from this study with that of the dataset supporting PMA approval using descriptive statistics

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids	NCT01377519	Uterine Fibroid...	MR Guided Focus... Placebo MR Guid...	18 Years - 99 Years	University of California, San Francisco
MRG FU With Radiotherapy for Palliation of H&N Cancer	NCT03218475	Head and Neck C...	MR Guided Focus...	18 Years -	Sunnybrook Health Sciences Centre
Magnetic Resonance Guided Focused Ultrasound for Uterine Fibroids	NCT01377519	Uterine Fibroid...	MR Guided Focus... Placebo MR Guid...	18 Years - 99 Years	University of California, San Francisco
MRG FU With Radiotherapy for Palliation of H&N Cancer	NCT03218475	Head and Neck C...	MR Guided Focus...	18 Years -	Sunnybrook Health Sciences Centre
A Clinical Study to Evaluate Safety of the ExAblate 2100 UF V2 System in the Treatment of Symptomatic Uterine Fibroids	NCT01092988	Uterine Fibroid... Bleeding Pain	Exablate 2100	18 Years -	InSightec

Spots Global Cancer Trial Database for mr guided focused ultrasound