Evaluation of Targeted Radiofrequency Ablation and Vertebral Augmentation prior to or following Radiation Therapy to Treat Painful Metastatic Vertebral Body Tumor(s)

What we are studying

The study goal is to evaluate the effect of the STAR Tumor Ablation System and StabiliT Vertebral Augmentation System (both manufactured by DFINE Inc.) on pain level, quality of life and ability to function of patients who have painful metastatic spinal tumors. The study procedures involve using a heating element to destroy tumor in the vertebral body (STAR system) followed by injecting bone cement (StabiliT System) which is a type of polymethylmethacrylate (PMMA); into the vertebrae. This system has a heating cartridge, through which the cement runs and, is designed to increase its viscosity (thickness) just prior to being delivered into the bone(s).

Who we are studying

  • Men and Women
  • Races:
    • White
    • African American
    • Asian
    • American Indian or Alaska Native
    • Native Hawaiian or Pacific Islander
    • Other
  • All Ethnicities
  • Ages 18+

Eligibility Criteria

  • One to two painful vertebrae (T1-L5) with evidence of osteolytic or mixed lytic and blastic metastatic lesion by cross sectional imagine and pathologic fracture (presence of non-painful vertebrae with metastatic lesions in addition to the painful index vertebrae are allowed)
  • Never received radiation therapy at index level(s) OR received radiation therapy without adequate relief from metastatic bone pain as determined by the patient and treating physician
  • Life expectancy >6 months

What is involved

  • 1 baseline visit
  • 1 procedure
  • 4 telephone calls
  • 4 follow-up visits



Contact Information

Study Coordinator
Emily Ansusinha
Principal Investigator
Clifford Howard, M.D.

Disclaimer: The information on this website is for general informational purposes only and SHOULD NOT be relied upon as a substitute for sound professional medical advice, evaluation or care from your physician or other qualified health care provider.