Dear ThermoOncology Followers,

In this post, we are discussing about the active clinical trials in the Hyperthermia treatment research in the US and Canada. If you are interested in joining a research study that is testing hyperthermia, search for research studies by using the advanced clinical trials search form (Cancer.gov) or contact NCI’s Cancer Information Service.

As you may know, in hyperthermia clinical trials, physicians are studying the benefoits, drawbacks and effectiveness of hyperthermia for treating breast cancer. Moreover, some clinical trials focus on improving techniques for delivering hyperthermia.

The two active breast cancer hyperthermia clinical trials are as follow:

1

Lead Organization:

NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

• OBJECTIVE:

To demonstrate the initial clinical feasibility of using Harmonic Motion Imaging (HMI) for Focused Ultrasound Surgery (FUS) guiding and monitoring in patients with benign and stage 1 non-metastatic breast cancers.

• Description

This clinical trial assess how harmonic motion imaging guided focused ultrasound surgery can be used in the clinic in treating women with breast tumors. Focused ultrasound surgery is a procedure in which high-energy sound waves are aimed directly at an area of abnormal cells or tissue in the body. The waves create heat that kills the cells. Several imaging techniques are currently being investigated for real-time treatment monitoring of focused ultrasound surgery. Many of these techniques monitor the temperature rise that occurs with thermal ablation. However, some of these methods can be time-consuming, which is not ideal for real-time monitoring; expensive; or prone to errors. This trial uses a technique called harmonic motion imaging that measures tissue stiffness, which may be better than imaging techniques that measure temperature changes during treatment with focused ultrasound surgery.

2

• Lead Organization:

Huntsman Cancer Institute/University of Utah

• OBJECTIVES:

* PRIMARY OBJECTIVE:

I. To evaluate the safety and tolerability of soft tissue ablation with the Muse MRgFUS system as assessed by subject-reported procedural pain and incidence of device- and procedure-related adverse device effects and adverse events.

* SECONDARY OBJECTIVES:

I. To estimate ablation efficacy.

II. To estimate disease-free survival (DFS) at 5 years post ablation.

III. To estimate overall survival in this study population at 5 years post ablation.

* EXPLORATORY OBJECTIVES:

I. To evaluate subject preference for treatment of localized breast cancer with the Muse MRgFUS System and identify the potential trade-offs they would be willing to accept.

II. To evaluate correlation between the change in lactate dehydrogenase (LDH) levels and ablation efficacy.

• Description

This phase I trial tests the safety and tolerability of a new investigational device, MUSE Magnetic Resonance Guided Focused Ultrasound System (MRgFUS) System in treating patients with breast cancer. The MRgFUS System destroys part of the tumor through the use of heat from a focused ultrasound (thermal ablation) that is guided by magnetic resonance imaging (MRI). Focused ultrasound is a sound wave that is focused down to a small point, about the size of a grain of rice, similar to the way a magnifying glass can focus light. The focused waves heat up tissue, causing tissue damage. The MRgFUS System may be a less invasive way to treat breast cancer.