Radiofrequency Ablation of Painful Soft Tissue Neoplasms
|ClinicalTrials.gov Identifier: NCT00041886|
Recruitment Status : Completed
First Posted : July 19, 2002
Last Update Posted : March 4, 2008
Radiofrequency ablation is used to treat patients with many different conditions. It is used to treat heart arrhythmia and benign bone tumors, and to control bleeding during surgery. It has been approved by the Food and Drug Administration for soft tissue ablation (removal). The technique involves inserting a probe, guided by computed tomography or ultrasound, and sending radio waves through the probe. The radio waves generate heat, which both destroys adjacent tissue and cauterizes blood vessels.
This study will enroll 15 adults (age 18 or older) with soft tissue metastases who suffer pain that is not well controlled by other means, such as drugs. The goal is to reduce their pain or their use of analgesics by partially destroying some of their tumors.
Patients will be ineligible for the study if they change the class of pain medication they use within 2 weeks before or 2 weeks after the study treatment. Patients will fill out short questionnaires about pain and daily activities (Brief Pain Inventory) before treatment and 1 day, 1 week, 1 month, 3 months, and 12 months after treatment to ascertain whether their pain is better controlled with less pain medication.
For the treatment, most patients will receive local anesthetic in the area where the probe is inserted. Some patients may require general anesthesia. The probe will remain in place typically for 10 to 30 minutes. For larger tumors, it may be inserted at different positions.
|Condition or disease|
|Soft Tissue Neoplasms|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Radiofrequency Ablation of Painful Soft Tissue Neoplasms|
|Study Start Date :||July 2002|
|Estimated Study Completion Date :||June 2005|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00041886
|United States, Maryland|
|Warren G. Magnuson Clinical Center (CC)|
|Bethesda, Maryland, United States, 20892|