CLINICAL TRIAL FACT SHEET
ExAblate (MRI-guided Focused Ultrasound Surgery)
ExAblate (MRI-guided Focused Ultrasound Surgery)
Treatment of Metastatic Bone Tumors for the Palliation of Pain
(continued)
A Pivotal Study to Evaluate the Effectiveness and Safety of ExAblate Treatment of Metastatic Bone and Multiple
Myeloma Tumors for the Palliation of Pain in Patients Who Are Not Candidates for Radiation
Trial Description: This is a randomized, single-blind (patient), placebo-controlled, parallel-assignment, safety/
efficacy study for myeloma patients with bone pain who are not candidates, fail, refuse, or their physician does not
recommend radiation.
Trial Objectives: To assess the effectiveness and safety of ExAblate, which is designed to heat the bone periosteum
with focused ultrasound in order to ablate the sensory origin of the patient's pain.
Major Inclusion Criteria:
· Patients who have painful multiple myeloma bone lesions and are not candidates for radiation.
· Patients who refuse additional radiation therapy
· Patients for whom the treating physician would not prescribe radiation or additional radiation treatments
· Patients with NRS pain score 4 irrespective of medicatio
Major Exclusion Criteria:
ns
· Patients who need surgical stabilization of the affected bony structure
· Targeted tumor is at an impending fracture site
· Patients with surgical stabilization of tumor site with metallic hardware
· More than 5 painful lesions.
· Targeted tumor is in the skull
· Patients with standard contraindications for MRI
Location and Contact Information:
University of California San Diego, La Jolla, CA: Bob Halterman, 619-543-5830, rhalterman@UCSD.edu
University of California Los Angeles, Los Angeles, CA: Polly Kay, RN, 310-794-0376, pkay@mednet.ucla.edu
Moffitt Cancer Center, Tampa, FL: Larry Milks, 813-745-2264, larry.milks@moffitt.org
University MRI & Diagnostic Imaging Centers, Boca Raton, FL: Kim Thomas, 561-362-9191,
kimthomas@exploreflorida.com
Brigham and Women's Hospital, Boston, MA: Louise Greenberg, 617-732-5441, lgreenberg@partners.org
Virtua Health, Vorhees, NJ: Margaret Brown, 856-325-4428, mbrown2@virtua.org
(locations continue on next page)
International Myeloma Foundation
International Myeloma Foundation
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · www.myeloma.org
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · www.myeloma.org
ExAblate (MRI-guided Focused Ultrasound Surgery)
(continued)
Weill Cornell Medical College, New York, NY: Amelia Ng, 212-746-2194, ameng@med.cornell.edu
Memorial Sloan Kettering Cancer Center, New York, NY: Tamara Torres Polanco, 212-639-2584,
torrest@mskcc.org
Fox Chase Cancer Center, Philadelphia, PA: Elaine Callahan, 215-728-3117, e_callahan@fccc.edu
Methodist Hospital Research Institute, Houston, TX: Jose Tenorio, 713-441-3247, jtenorio@tmhs.org
UVA Department of Radiation Oncology Box 800383, Charlottesville VA 22908, Paul Read, 434-924-9288,
fax 434-243-9789, PWR3U@hscmail.mcc.virginia.edu
···
Toronto General Hospital, Toronto, ON, Canada: Cjeryl Geen-Smith, 416-340-4800 ext 6639,
cgsmith@uhnresearch.ca
Rambam Medical Center Pain Palliation Unit, Haifa, Israel: May Hadad, 972-4-8541931
Sheba Medical Center, Tel Hashomer, Israel: Rama Sapir, 02-6555768, sapir@szmc.org.il;
Natasha Bardy, nataliabard@rambler.ru
College of Medicine, Pochon CHA Univeristy, Gyunggi-do, Republic of Korea:
Sang-Wook Yoon, +82317805998, jansonrad@gmail.com
N.N. Petrov Institute of Oncology, St. Petersburg, Russian Federation:
V.G. Turkevich, +78125968607, 5968900@mail.ru
St. Mary's Hospital, London, United Kingdom: Philippa Tyler, 02078862041
Rostov Oncology Research Institute, Rostov-on-Don, Russian Federation; the investigator is Iozeffi Dmitri
Additional Resource
www.mycancerpain.org
International Myeloma Foundation
International Myeloma Foundation
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
12650 Riverside Drive, Suite 206, North Hol ywood, CA 91607 USA
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · www.myeloma.org
Telephone: 800-452-CURE (2873) (USA & Canada)
818-487-7455 (worldwide) · TheIMF@myeloma.org · www.myeloma.org