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Cryoablation for the Palliation of Painful Bone Metastases

Phase 1
18 Years
Open (Enrolling)
Pain, Neoplasm Metastasis

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Trial Information

Cryoablation for the Palliation of Painful Bone Metastases

Patients with painful bone metastases 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. Cryoablation is the process of destroying tissue by the
application of extremely cold temperatures. Galil Medical Cryoablation Systems are used as
a surgical tool in the fields of general surgery, dermatology (skin), neurology (nerves),
chest surgery (including lung), Ears-Nose-Throat (ENT), gynecology, oncology (cancer),
proctology (colon/rectal) and urology (kidney).

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 be followed for up to 24 weeks
(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

Inclusion Criteria:

- 18 years of age or older

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

- Current analgesic therapies have failed OR the subject is experiencing intolerable
side effects

- Unremitting pain that resulted in a return visit to the oncologist. 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) despite pharmaceutical pain management

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

- Pain from the reported one or two metastatic sites must correlate with an
identifiable tumor on CT, MRI, or ultrasound (US) imaging

- Tumors must be suitable for cryoablation

- Cryoablation should be performed within 14 days of baseline evaluations

- Stable use of hormonal therapy (no changes within 4 weeks prior to the cryoablation

- Stable use of pain medications (no changes within 2 weeks prior to the cryoablation

- ECOG (Eastern Cooperative Oncology Group) scale performance status 0-3

- Life expectancy ≥ 2 months

- Platelet count >50,000/mm³ within 6 weeks screening

- INR (International Normalized Ratio) <1.5 within 6 weeks screening

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

- If taking antiplatelet or anticoagulation medication, it must be able to be
discontinued prior to the procedure for an appropriate amount of time (e.g., aspirin,
ibuprofen, low molecular weight heparin preparations)

- Clinically suitable for cryoablation therapy

Exclusion Criteria:

- Leukemia, lymphoma, and myeloma

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

- Has undergone prior ablation treatment of the index tumor

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

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

- Anticipated treatment of the index tumor that would require iceball formation within
1.0 cm of the spinal cord, brain, other critical nerve structure, large abdominal
vessel such as the aorta or inferior vena cava, bowel, or bladder

- Surgery at the tumor site or surgery involving the cryoablation-treated tumor (index

- Index tumor involves the skull (treatment of other painful tumors in subjects with
skull tumors is not excluded)

- Patient currently with neutropenia (absolute neutrophil count <1000) within 6 weeks

- Uncontrolled coagulopathy or bleeding disorders

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

- Active, uncontrolled infection

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

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Difference in worst pain scores

Outcome Description:

The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation associated with palliation of pain in subjects with metastatic bone cancer by measuring the average difference of pre- and posttreatment worst pain in 24 hours from baseline to 24 hour, 1, 4, 12, and 24 week follow-up intervals as measured on the numeric 0 to 10 Brief Pain Inventory (BPI) scale.

Outcome Time Frame:

24 weeks post-cryoablation

Safety Issue:


Principal Investigator

Jerry Matteo, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Shands Medical Center, Jacksonville, FL


United States: Institutional Review Board

Study ID:




Start Date:

November 2011

Completion Date:

January 2014

Related Keywords:

  • Pain
  • Neoplasm Metastasis
  • Painful bone metastases
  • Bone metastases
  • Metastatic bone tumors
  • Metastatic bone pain
  • Cryoablation
  • Cryotherapy
  • Cryosurgery
  • Neoplasms
  • Neoplasm Metastasis
  • Neoplasms, Second Primary
  • Bone Neoplasms
  • Bone Marrow Diseases



University of Texas M.D. Anderson Cancer CenterHouston, Texas  77030
Karmanos Cancer InstituteDetroit, Michigan  48201