Photodynamic Therapy for the Treatment of Vertebral Metastases
Status:
Completed
Trial end date:
2017-09-07
Target enrollment:
Participant gender:
Summary
An estimated 10 percent of primary breast, prostate, lung, thyroid and renal cell tumors
metastasize to the spine. The majority of these tumors are detected before surgical
intervention is required and most patients receive radiation therapy for symptomatic relief.
Complete pain control, duration of pain control, high recurrence rates and soft tissue
complications make radiation a less than ideal treatment. Also, pre-operative radiation
therapy is a significant negative predictor for surgical outcomes. To improve the treatment
options for patients with advanced cancer with spinal lesions the research team investigated
a new minimally invasive therapy known as photodynamic therapy (PDT) that targets metastatic
spine lesions with limited side effects. PDT involves the use of a photo-activated
chemotherapeutic agent, given intravenously that when stimulated by non-thermal
wavelength-specific light allows for selective ablation of tumor tissue. The light is
delivered to the spine through small fiber optic cables using a diode laser. By combining
canine and porcine studies the investigators have strong evidence to support that PDT is both
safe and effective for the treatment of metastatic tumors in the spine. PDT is targeted,
repeatable, minimally invasive and has limited local and systemic side effects. Its use would
enhance the treatment options for patients with advanced stage cancer. The goal of the
present study is to demonstrate that PDT can be safely and effectively given to treat spinal
metastases in patients with advanced stage cancer who have multiple lesions or who have
failed radiation or surgical intervention. The effectiveness of this treatment will be
determined through clinical and radiographic endpoints along with recurrence and survival.
The investigators intend to demonstrate that PDT is a minimally invasive method with low
morbidity and mortality by which spinal tumors can be ablated and later stabilized through
vertebroplasty, optimizing quality of life and providing effective treatment.