Who can participate in the study?
Patients who have been diagnosed with bone metastases or multiple myeloma and have up to five painful bone metastases with one much more painful than the others, preferably in the pelvis, arms, legs, ribs or shoulders.
Patients should be able to undergo MR imaging exam .
What will happen if I take part in the study?
You will undergo an MRI scan to determine your eligibility for the study.
If you are eligible you may be in the study for up to seven months. During this period, there will be periodic appointments to monitor the success of the treatment in relieving your pain from the treated bone metastasis.
What does participating in the study entail?
- All volunteers will be required to sign consent forms to participate in the study.
- The treatment will be performed in an open MRI. Treatment should take a few hours and the patient should be able to return home following the procedure.
- Investigators will ask the participants to grade the degree of pain they’re suffering on a scale and to keep track of the how frequently they take analgesic pain killers to manage their bone mets pain and the doses of these medications.
Has this technology ever been studied before in bone metastases?
Promising results from other studies indicate that ExAblate treatment may be an effective therapy for reducing pain caused by bone metastases in patients who are not candidates for additional radiation therapy. The goal of this study is to confirm those earlier results, but the treatment should be considered experimental at this time.
To read the abstracts of these studies, click on the following links:
Liberman B, Gianfelice D, Inbar Y, Beck A, Rabin T, Shabshin N, Chander G, Hengst S, Pfeffer R, Chechick A, Hanannel A, Dogadkin O, Catane R. Pain Palliation in Patients with Bone Metastases Using MR-Guided Focused Ultrasound Surgery: A Multicenter Study, Annals of Surgical Oncology, 2008.
Gianfelice D, Gupta C, Kucharczyk W, Bret P, Havill D, Clemons M. Palliative Treatment of Painful Bone Metastases with MR Imaging-guided Focused Ultrasound, Radiology, 2008.
Catane R, Beck A, Inbar Y, Rabin T, Shabshin N, Hengst S, Pfeffer RM, Hanannel A, Dogadkin O, Liberman B, Kopelman D. MR-guided Focused Ultrasound Surgery (MRgFUS) for the Palliation of Pain in Patients with Bone Metastases-Preliminary Clinical Experience, Annals of Oncology, 2006, 18(1):163-7.
What are the benefits of MRgFUS?
MRgFUS is a non-invasive treatment to relieve pain caused by bone metastases.
• It is non-invasive, so no incisions or probes are needed
• Only one treatment is usually required
• There is no radiation
In previous trials, patients have reported pain relief within three days, without other side effects.
What are some of the risks of the procedure?
There are no known serious side effects. MRgFUS could cause some pain or a skin burn. There is the possibility of damage to other tissues, but this is minimized through MR imaging which shows the exact location of the focused ultrasound. You could have an allergy to the MRI dye or the pain medication. There may be other risks that your doctor will discuss with you.
What is the cost?
There is no cost to you for being in this study.
How long does the procedure take?
The entire MRgFUS procedure will take up to two hours.
Is ExAblate approved?
ExAblate treatment is approved for the treatment of uterine fibroids, non-cancerous tumors that grow in women’s uteruses, but its use for the palliation of pain from bone metastases is experimental.
Have further questions?
Please contact us at: info@insightec.com or click here to find the nearest treatment location to you.
