Researchers at Stanford University are now recruiting 30 patients to participate in a feasibility study to evaluate the safety and effectiveness of focused ultrasound for treating soft tissue tumors, such as sarcoma or desmoid tumors. This study is being led by radiologist Dr. Pejman Ghanouni and orthopedic surgeon Dr. Raffi Avedian. Drs. Ghanouni and Avedian received U.S. Food and Drug Administration approval and were awarded a National Institutes of Health (NIH) grant to conduct this study based on their experience treating five patients on a compassionate use basis. The pair plans to present their preliminary findings at the ISTU meeting in April.
“We applaud the initiative taken by Drs. Ghanouni and Avedian. They identified a serious medical condition with an unmet clinical need that focused ultrasound could potentially treat; they obtained regulatory approval to do the study; and they presented a compelling case to be awarded NIH funding,” said Dr. Neal F. Kassell, Foundation Chairman. “We are hopeful that focused ultrasound will be an effective non-invasive treatment option for this devastating disease.”
Surgical vs. Nonsurgical
The study will be open to patients who are eligible for surgery and those who are not eligible for surgery. The surgical group will undergo focused ultrasound treatment on part of the tumor before its surgical removal. Those who are not eligible for surgery will undergo only the focused ultrasound treatment to heat and destroy tumor tissue. Physicians will examine both groups of patients for changes in pain and limb function before and after the focused ultrasound treatment and assess the accuracy and percentage of the tumor destroyed. Safety will be determined by evaluating the incidence and severity of any device-related complication.
The criteria to determine if a patient is appropriate for this study include:
- Males and females at least 10 years of age
- Patients who have benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders that require surgical intervention
- Tumor must not have been treated previously with radiation
- Patients must be able to safely undergo MRI exam and tolerate being in the MRI scanner for the duration of the study treatment
Complete criteria and enrollment information is available on www.clinicaltrials.gov under study number NCT01965002.
Pejman Ghanouni, MD, PhD
Assistant Professor, Department of Radiology
Stanford University School of Medicine
Raffi Avedian, MD
Assistant Professor, Orthopedic Surgery
Stanford University Medical Center