Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Patients with painful metastatic lesions involving bone who meet the eligibility criteria and
who have been determined to be an appropriate candidate for cryoablation therapy will be
offered enrollment into the study. Patients agreeing to participate will read and sign an
informed consent form and thus become subjects in the study. Treatment will be performed
using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Subjects
will have one cryoablation procedure and will be followed for up to 6 months for palliation
of pain, quality of life and analgesic usage. Baseline and follow-up data will be collected
for each subject via a web-based electronic data collection tool.

Inclusion Criteria:

- 18 years of age or older

- Metastatic disease involving bone with metastatic disease previously confirmed by
prior biopsy; or Metastatic disease involving bone previously confirmed on imaging
(e.g. CT or MRI) with known (biopsied) primary disease (primary bone cancer is
excluded)

- Current analgesic therapies have failed, the subject is not a candidate for, OR the
subject is not experiencing adequate pain relief from current pain therapies (e.g.
radiation, analgesics)

- The 'worst pain' in the last 24 hours must be reported to be 4 or above on a scale of
0 (no pain) to 10 (pain as bad as subject can imagine)

- Pain must be from one painful metastatic lesion involving the bone that is amenable to
cryoablation with CT (additional less painful metastatic sites may be present)

- Cryoablation should be performed within 14 days of screening visit

- If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to
the cryoablation procedure)

- Karnofsky Performance Scale (KPS) score ≥60

- Life expectancy ≥ 3 months

- No debilitating medical or psychiatric illness that would preclude giving informed
consent or receiving optimal treatment and follow-up

- Known coagulopathy or bleeding disorders are controlled

Exclusion Criteria:

- Primary cancer is leukemia, lymphoma, or myeloma

- Tumor involves a weight-bearing long bone of the lower extremity with the tumor
causing > 50% loss of cortical bone

- Has undergone prior surgery at the tumor site or the index tumor has undergone
previous surgery or ablation treatment

- Prior radiation therapy of the index tumor <3 weeks prior to the screening visit

- Index tumor causing clinical or radiographic evidence of spinal cord or cauda equina
compression/effacement

- Anticipated treatment of the index tumor that would require iceball formation within
0.5 cm of the spinal cord, brain, other critical nerve structure, large abdominal
vessel (possibly achieved with additional maneuvers such as hydrodissection)

- Index tumor involves the skull

- Currently pregnant, nursing, or wishing to become pregnant during the study

- Serious medical illness, including any of the following: uncontrolled congestive heart
failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6
months prior to the screening visit

- Concurrent participation in other studies that could affect the primary endpoint