Percutaneous US and CT-Guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed metastatic solid tumor involving or
abutting bone (index lesion)

- If the nature of the metastatic disease has been previously documented, index
lesion to be treated does not require further documentation (i.e., biopsy)

- Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or
analgesics) or patient is considered a poor candidate for conventional therapies

- Radiation oncology consult is required if the patient is considered clinically
to be a candidate for conventional palliative radiotherapy

- Surgical oncology consult is required if the patient is considered clinically to
be a candidate for conventional surgical treatment or is considered at risk for
complications resulting from potential fracture

- Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by
circling the one number that best describes your pain at its worst in the past 24
hours" on the Cleeland Brief Pain Inventory

- Pain from ≤ 2 sites of metastatic disease

- No lesions with evidence for impending fracture involving a weight-bearing bone (>
50% loss of cortical bone at the site)

PATIENT CHARACTERISTICS:

- Life expectancy ≥ 2 months

- Platelet count ≥ 75,000/mm³

- ANC > 1,500/mm³ (for patients who have recently been treated with chemotherapy)

- INR ≤ 1.2

- Not pregnant or nursing

- Negative pregnancy test

PRIOR CONCURRENT THERAPY:

- More than 3 weeks since prior radiotherapy

- More than 3 weeks since initiation of a new chemotherapy regimen, including
bisphosphonates

- More than 7 days since prior antiplatelet medications or clopidogrel

- More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other
NSAIDs

- No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or
brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena
cava, or within 1 cm of bowel or bladder

- No prior radiofrequency ablation for pain palliation of the same lesion

- No concurrent regular or low molecular weight heparin or other anticoagulants