Cryoablation for the Palliation of Painful Bone Metastases
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- Boston Scientific Corporation
- Enrollment
- 29
- Locations
- 4
- Primary Endpoint
- Difference in worst pain scores
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.
Detailed Description
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 tool.
Investigators
Eligibility Criteria
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 procedure)
- •Stable use of pain medications (no changes within 2 weeks prior to the cryoablation procedure)
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 compression/effacement
- •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 tumor)
- •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 screening
- •Uncontrolled coagulopathy or bleeding disorders
Outcomes
Primary Outcomes
Difference in worst pain scores
Time Frame: 24 weeks post-cryoablation
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.
Secondary Outcomes
- Subject satisfaction with the amount palliation of pain obtained from cryoablation(24 weeks post-cryoablation)
- Cryoablation retreatments(24 weeks post-cryoablation)
- Additional surgical treatments other than cryoablation(24 weeks post-cryoablation)
- Reduced analgesic usage(24 weeks post-cryoablation)
- Time to maximal palliation of pain after cryoablation(24 weeks post-cryoablation)
- Number of adverse events(30 days post-cryoablation)
- Difference in average pain scores(24 weeks post-cryoablation)
- Time to recurrence of worst pain(24 weks post-cryoablation)