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A Phase IV Post Approval Clinical Study of ExAblate Treatment of Metastatic Bone Tumors for the Palliation of Pain

Clinical Trial Details

DO YOU SUFFER FROM PAIN ASSOCIATED WITH BONE METASTASES OR MULTIPLE MYELOMA?

If so, you may be eligible to participate in a research study being conducted at Weill Cornell Medical College.

This study is collecting additional effectiveness and safety information for the relief of painful bone tumors using Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy provided by a medical device called ExAblate.

This is a non-invasive (without surgery) procedure that is already FDA approved for relieving pain due to tumors that have spread to the bone.

During the treatment you will lie on the ExAblate device table in a magnetic resonance imaging (MRI) scanner. The device produces focused ultrasound waves that generate sufficient heat to destroy the pain-causing nerves in the bone surface surrounding the tumor. Magnetic Resonance Imaging (MRI) is used not only to visually pinpoint the focused ultrasound heating on the bone where the tumor is causing pain, but also to continuously monitor the tissue temperature changes of the target area in real time. The ultrasound waves generated by the device pass through skin and into the body, so no incisions or probes inserted through the skin are needed.

Study participation includes visits to Weill Cornell Medical College for: 

  • Screening to determine eligibility
  • Follow up visits in person & over the phone up to three months after the ExAblate procedure
Key Eligibility: 
  • Men & Women 18 years and older
  • Diagnosed with bone metastases or multiple myeloma suffering from bone pain and for whom radiation therapy is not an alternative
  • Other criteria to be discussed with your doctor or the research team

Contact

Eileen Chang
eic2002@med.cornell.edu
(212) 746-2600

Primary Investigator

David Li, M.D., Ph.D.

Protocol ID(s)

Weill Cornell Medicine IRB #:

1505016170

Status:

Open to Enrollment

Sponsor

Drug/Device

Device

Study Type

Phase

4