Loyola University Medical Center has launched the first clinical trial in the United States to test a new combination treatment that delivers radiation directly to the tumor and increases support of the spine.
The minimally invasive treatment is designed to help relieve pain, heal spinal fractures and prevent new fractures, according to a press release.
The purpose of the phase 1 study, titled “Combining intraoperative radiotherapy with kyphoplasty for treatment of spinal metastases (Kypho-IORT),” is to learn about both the good and bad effects of combining intraoperative radiotherapy and kyphoplasty.
As the first step in the procedure, an interventional radiologist makes a small incision into the spine and inserts a spinal applicator needle to deliver a higher dose of radiation directly to the tumor. The second half of the operation is a kyphoplasty, where a catheter is inserted through the incision and a balloon at the tip of the catheter is inflated to increase the height of the collapsed vertebra. Cement is the injected into the radiated area to help stabilize the spine, according to the release.
Researchers will compare patients’ pain levels and use of pain medications before and after the procedure, in addition to monitoring any quality-of-life issues, the procedure’s effects and any complications that may arise.
The study is sponsored by the departments of Radiation Oncology and Radiology of Loyola University Chicago Stritch School of Medicine and will be lead by William Small Jr., MD, according to the release.