Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

Phase 1

Completed

• Conditions: Neoplasm Metastasis; Pain
• Interventions: Procedure: Cryoablation

• Registration Number: NCT01461265
• Lead Sponsor: Boston Scientific Corporation

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.

Study Timeline

• Study First Submitted: 2011-10-25
• Study First Submitted QC: 2011-10-26
• Study First Posted: 2011-10-28
• Study Start: 2011-11
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-15
• Last Update Posted: 2021-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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)
• 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 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
• 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 endpoint

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	All subjects will have cryoablation on one or two painful metastatic bone tumors.

Primary Outcome Measures

Name	Time	Method
Difference in worst pain scores	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 Outcome Measures

Name	Time	Method
Subject satisfaction with the amount palliation of pain obtained from cryoablation	24 weeks post-cryoablation	Subject satisfaction will be compared at baseline to follow-up intervals.
Cryoablation retreatments	24 weeks post-cryoablation	If the first cryoablation procedure effectively relieves pain but the relief wears off over time and the pain becomes unbearable, a second procedure may be performed. The number of repeat cryoablation treatments will be recorded.
Additional surgical treatments other than cryoablation	24 weeks post-cryoablation	If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.
Reduced analgesic usage	24 weeks post-cryoablation	The number of subjects (percentage) who are able to reduce analgesic medications from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation will be recorded.
Time to maximal palliation of pain after cryoablation	24 weeks post-cryoablation	The difference in pain scores will be assessed from baseline to follow-up intervals after cryoablation will be analyzed. The interval indicating the most relief from pain will be compared across subjects.
Number of adverse events	30 days post-cryoablation	The safety endpoint for this study is to assess the incidence and severity of intra-operative events, post operative adverse events, serious adverse events and unanticipated adverse device effects related to the cryoablation procedure.
Difference in average pain scores	24 weeks post-cryoablation	Difference in average pain scores from baseline to 24 hours, 1, 4, 12, and 24 weeks after cryoablation as measured on the numeric 0 to 10 BPI scale
Time to recurrence of worst pain	24 weks post-cryoablation	Time to recurrence of worst pain at or above baseline; worst pain score in the 24 week follow-up period as measured on the numeric 0 to 10 BPI scale

Trial Locations

Locations (4)

University of Texas M.D. Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

University Hospital of Strasbourg; 🇫🇷 Strasbourg, France

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada