This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain
associated with metastatic bone tumors.
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Full eligibility criteria for NCT01461265
Ages eligible for Study
18 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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
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
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
All locations for NCT01461265
United States (5)
Atlanta, Georgia, United States, 30322
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Rochester, Minnesota, United States, 55905
St. Louis, Missouri, United States, 63130
Houston, Texas, United States, 77030
University of British Columbia
Vancouver, British Columbia, Canada, V5Z 1L8
University Hospital of Strasbourg
Strasbourg, France, F-67091
View full eligibility
Tris trial is registered with FDA with number: NCT01461265. The sponsor of the trial is Boston Scientific Corporation and it is looking for 29 volunteers for the current phase.
Official trial title: Cryoablation for the Palliation of Painful Bone Metastases
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