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

18 Years
Open (Enrolling)
Metastatic Cancer, Pain, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


- To confirm the safety of percutaneous cryoablation in the palliative treatment of
patients with painful bone metastases.

- To determine the benefits of cryoablation of painful bone metastases by assessing pain
intensity using a standardized Cleeland Brief Pain Inventory (BPI) and quality of life
using a standardized SF-8 both before and after treatment.

- To determine the secondary benefits of cryoablation of painful bone metastases by
assessing change in analgesic use following therapy.

- To determine the level of anesthesia required for cryoablation with a baseline level of
conscious sedation planned for each treatment.

OUTLINE: This is a multicenter study.

Patients undergo percutaneous cryoablation to one or two sites of metastatic disease using
the Endocare Cryocare system. Patients with a good initial response to treatment (≥ 2
decrease in pain intensity rating on the Brief Pain Inventory) who develop recurrent pain at
the same site or a new painful site ≥ 1 month after initial treatment may undergo one
additional cryoablation treatment.

Patients complete pain and quality of life questionnaires periodically.

After completion of study treatment, patients are followed periodically for 2 years.

Inclusion Criteria


- 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)


- 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


- More than 3 weeks since prior radiotherapy

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

- More than 7 days since prior antiplatelet medications or clopidogrel

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

- 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

Type of Study:


Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8

Safety Issue:


Principal Investigator

Matthew R. Callstrom, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

November 2003

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific
  • bone metastases
  • pain
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Memorial Sloan-Kettering Cancer Center New York, New York  10021
University of Michigan Comprehensive Cancer Center Ann Arbor, Michigan  48109-0752
Mayo Clinic - Jacksonville Jacksonville, Florida  32224
Mayo Clinic Cancer Center Rochester, Minnesota  55905
Barbara Ann Karmanos Cancer Institute Detroit, Michigan  48201
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
University of Wisconsin Paul P. Carbone Comprehensive Cancer Center Madison, Wisconsin  53792-6164
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center Milwaukee, Wisconsin  53201-2901
NYU Cancer Institute at New York University Medical Center New York, New York  10016
Brown University School of Medicine Providence, Rhode Island  02905