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

Pain Clinical Trial

Official title:

Cryoablation for the Palliation of Painful Bone Metastases

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461265
• Other study ID #: CUC10-BNE11
• Status: Completed
• Phase: Phase 1
• Start date: November 2011
• Est. completion date: April 2015

Study information

• Verified date: July 2021
• Source: Boston Scientific Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will evaluate the safety and efficacy of cryoablation therapy for relief of pain associated with metastatic bone tumors.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm Metastasis
• Neoplasms, Second Primary
• Pain

Intervention

Procedure:
• Cryoablation
For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.

Locations

Country	Name	City	State
Canada	University of British Columbia	Vancouver	British Columbia
France	University Hospital of Strasbourg	Strasbourg
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	University of Texas M.D. Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  Canada,  France, 

References & Publications (6)

Callstrom MR, Atwell TD, Charboneau JW, Farrell MA, Goetz MP, Rubin J, Sloan JA, Novotny PJ, Welch TJ, Maus TP, Wong GY, Brown KJ. Painful metastases involving bone: percutaneous image-guided cryoablation--prospective trial interim analysis. Radiology. 2006 Nov;241(2):572-80. — View Citation

Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. — View Citation

Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. Review. — View Citation

Goetz MP, Callstrom MR, Charboneau JW, Farrell MA, Maus TP, Welch TJ, Wong GY, Sloan JA, Novotny PJ, Petersen IA, Beres RA, Regge D, Capanna R, Saker MB, Grönemeyer DH, Gevargez A, Ahrar K, Choti MA, de Baere TJ, Rubin J. Percutaneous image-guided radiofrequency ablation of painful metastases involving bone: a multicenter study. J Clin Oncol. 2004 Jan 15;22(2):300-6. — View Citation

Simon CJ, Dupuy DE. Percutaneous minimally invasive therapies in the treatment of bone tumors: thermal ablation. Semin Musculoskelet Radiol. 2006 Jun;10(2):137-44. Epub 2006 Apr 5. Review. — View Citation

Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in worst pain scores	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.	24 weeks post-cryoablation
Secondary	Cryoablation retreatments	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.	24 weeks post-cryoablation
Secondary	Additional surgical treatments other than cryoablation	If pain is not effectively relieved by the cryoablation, other surgical treatments may be performed. The number of these treatments will be recorded.	24 weeks post-cryoablation
Secondary	Reduced analgesic usage	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.	24 weeks post-cryoablation
Secondary	Time to maximal palliation of pain after 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.	24 weeks post-cryoablation
Secondary	Subject satisfaction with the amount palliation of pain obtained from cryoablation	Subject satisfaction will be compared at baseline to follow-up intervals.	24 weeks post-cryoablation
Secondary	Number of adverse events	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.	30 days post-cryoablation
Secondary	Difference in average pain scores	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	24 weeks post-cryoablation
Secondary	Time to recurrence of worst pain	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	24 weks post-cryoablation