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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02511678
Other study ID # CGC15-BNE098
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 15, 2016
Est. completion date March 12, 2018

Study information

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

Clinical Trial Summary

This study will evaluate the efficacy of cryoablation for palliation of painful metastases in participants with metastatic lesions involving bone who have failed, are not candidates for, or are not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics).


Description:

Participants with painful metastatic lesions involving bone who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation therapy were offered enrollment into the study. Participants agreeing to participate will read and sign an informed consent form and thus become participants in the study. Treatment will be performed using a Galil Medical cryoablation system and Galil Medical cryoablation needles. Participants will have one cryoablation procedure and will be followed for up to 6 months for palliation of pain, quality of life, and analgesic usage. Baseline and follow-up data will be collected for each participant via a web-based electronic data collection tool.


Recruitment information / eligibility

Status Completed
Enrollment 73
Est. completion date March 12, 2018
Est. primary completion date March 12, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 18 years of age or older - Metastatic disease involving bone with metastatic disease previously confirmed by prior biopsy; or Metastatic disease involving bone previously confirmed on imaging (for example, computed tomography [CT] or magnetic resonance imaging [MRI]) with known (biopsied) primary disease (primary bone cancer is excluded) - Current analgesic therapies have failed, the participant is not a candidate for, or the participant is not experiencing adequate pain relief from current pain therapies (for example, radiation, analgesics) - 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 participant can imagine) - Pain must be from one painful metastatic lesion involving the bone that is amenable to cryoablation with CT (additional less painful metastatic sites may be present) - Cryoablation should be performed within 14 days of screening visit - If taking hormonal therapy, use should be stable (no changes within 4 weeks prior to the cryoablation procedure) - Karnofsky Performance Scale (KPS) score =60 - Life expectancy =3 months - No debilitating medical or psychiatric illness that would preclude giving informed consent or receiving optimal treatment and follow-up - Known coagulopathy or bleeding disorders are controlled Exclusion Criteria: - Primary cancer is leukemia, lymphoma, or myeloma - Tumor involves a weight-bearing long bone of the lower extremity with the tumor causing >50% loss of cortical bone - Has undergone prior surgery at the tumor site or the index tumor has undergone previous surgery or ablation treatment - Prior radiation therapy of the index tumor <3 weeks prior to the screening visit - 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 0.5 centimeters (cm) of the spinal cord, brain, other critical nerve structure, or large abdominal vessel (possibly achieved with additional maneuvers such as hydrodissection) - Index tumor involves the skull - Currently pregnant, nursing, or wishing to become pregnant during the study - Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, or cerebrovascular event within 6 months prior to the screening visit - Concurrent participation in other studies that could affect the primary endpoint

Study Design


Intervention

Device:
Cryoablation
The application of repeated freeze and thaw cycles to the identified tissues.

Locations

Country Name City State
France Institut Bergonié Bordeaux
France Centre Léon Bérard Lyon
France University Hospital of Strasbourg Strasbourg
France Institut Gustave Roussy Villejuif
United States Emory University Hospital Atlanta Georgia
United States Massachusetts General Hospital Boston Massachusetts
United States UCLA Ronald Reagan Medical Center Los Angeles California
United States Rhode Island Hospital Providence Rhode Island
United States Crittenton Hospital Rochester Michigan
United States Mayo Clinic Rochester Rochester Minnesota
United States Washington University in St. Louis Saint Louis Missouri

Sponsors (1)

Lead Sponsor Collaborator
Boston Scientific Corporation

Countries where clinical trial is conducted

United States,  France, 

References & Publications (38)

Belfiore G, Tedeschi E, Ronza FM, Belfiore MP, Della Volpe T, Zeppetella G, Rotondo A. Radiofrequency ablation of bone metastases induces long-lasting palliation in patients with untreatable cancer. Singapore Med J. 2008 Jul;49(7):565-70. — View Citation

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

Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. Review. — View Citation

Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12. — View Citation

Cleeland CS. The measurement of pain from metastatic bone disease: capturing the patient's experience. Clin Cancer Res. 2006 Oct 15;12(20 Pt 2):6236s-6242s. Review. — View Citation

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

COOPER IS, LEE AS. Cryostatic congelation: a system for producing a limited, controlled region of cooling or freezing of biologic tissues. J Nerv Ment Dis. 1961 Sep;133:259-63. — View Citation

Cozzi PJ, Lynch WJ, Collins S, Vonthethoff L, Morris DL. Renal cryotherapy in a sheep model; a feasibility study. J Urol. 1997 Feb;157(2):710-2. — View Citation

Gage AA, Baust JM, Baust JG. Experimental cryosurgery investigations in vivo. Cryobiology. 2009 Dec;59(3):229-43. doi: 10.1016/j.cryobiol.2009.10.001. Epub 2009 Oct 13. Review. — View Citation

Gage AA, Fazekas G, Riley EE Jr. Freezing injury to large blood vessels in dogs. With comments on the effect of experimental freezing of bile ducts. Surgery. 1967 May;61(5):748-54. — View Citation

Gage AA, Guest K, Montes M, Caruana JA, Whalen DA Jr. Effect of varying freezing and thawing rates in experimental cryosurgery. Cryobiology. 1985 Apr;22(2):175-82. — View Citation

Gage AA. Current progress in cryosurgery. Cryobiology. 1988 Oct;25(5):483-6. — View Citation

Gage AA. Progress in cryosurgery. Cryobiology. 1992 Apr;29(2):300-4. — View Citation

Gage AM, Montes M, Gage AA. Freezing the canine thoracic aorta in situ. J Surg Res. 1979 Nov;27(5):331-40. — 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

Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. Review. — View Citation

Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8. — View Citation

Hamilton A, Hu J. An electronic cryoprobe for cryosurgery using heat pipes and thermoelectric coolers: a preliminary report. J Med Eng Technol. 1993 May-Jun;17(3):104-9. — View Citation

Homasson JP, Thiery JP, Angebault M, Ovtracht L, Maiwand O. The operation and efficacy of cryosurgical, nitrous oxide-driven cryoprobe. I. Cryoprobe physical characteristics: their effects on cell cryodestruction. Cryobiology. 1994 Jun;31(3):290-304. — View Citation

Hurwitz MD, Ghanouni P, Kanaev SV, Iozeffi D, Gianfelice D, Fennessy FM, Kuten A, Meyer JE, LeBlang SD, Roberts A, Choi J, Larner JM, Napoli A, Turkevich VG, Inbar Y, Tempany CM, Pfeffer RM. Magnetic resonance-guided focused ultrasound for patients with painful bone metastases: phase III trial results. J Natl Cancer Inst. 2014 Apr 23;106(5). pii: dju082. doi: 10.1093/jnci/dju082. — View Citation

Ladd AP, Rescorla FJ, Baust JG, Callahan M, Davis M, Grosfeld JL. Cryosurgical effects on growing vessels. Am Surg. 1999 Jul;65(7):677-82. — View Citation

Maiwand MO, Homasson JP. Cryotherapy for tracheobronchial disorders. Clin Chest Med. 1995 Sep;16(3):427-43. Review. Erratum in: Clin Chest Med 1995 Dec;16(4):ix. — View Citation

Maiwand MO. The role of cryosurgery in palliation of tracheo-bronchial carcinoma. Eur J Cardiothorac Surg. 1999 Jun;15(6):764-8. — View Citation

Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope. 1967 Aug;77(8):1328-50. — View Citation

McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. Review. Update in: Cochrane Database Syst Rev. 2013;11:CD001793. — View Citation

McTaggart RA, Dupuy DE. Thermal ablation of lung tumors. Tech Vasc Interv Radiol. 2007 Jun;10(2):102-13. Review. — View Citation

Miller RH, Mazur P. Survival of frozen-thawed human red cells as a function of cooling and warming velocities. Cryobiology. 1976 Aug;13(4):404-14. — View Citation

Phillips DR, Milim SJ, Nathanson HG, Haselkorn JS. Experience with laparoscopic leiomyoma coagulation and concomitant operative hysteroscopy. J Am Assoc Gynecol Laparosc. 1997 Aug;4(4):425-33. — View Citation

Rabin Y, Coleman R, Mordohovich D, Ber R, Shitzer A. A new cryosurgical device for controlled freezing. Cryobiology. 1996 Feb;33(1):93-105. — View Citation

Rabin Y, Julian TB, Wolmark N. A compact cryosurgical apparatus for minimally invasive procedures. Biomed Instrum Technol. 1997 May-Jun;31(3):251-8. — View Citation

Rand RW, Rand RP, Eggerding FA, Field M, Denbesten L, King W, Camici S. Cryolumpectomy for breast cancer: an experimental study. Cryobiology. 1985 Aug;22(4):307-18. — View Citation

Rewcastle JC, Hahn LJ, Saliken JC, McKinnon JG. Use of a moratorium to achieve consistent liquid nitrogen cryoprobe performance. J Surg Oncol. 1997 Oct;66(2):110-3. — View Citation

Rewcastle JC, Sandison GA, Saliken JC, Donnelly BJ, McKinnon JG. Considerations during clinical operation of two commercially available cryomachines. J Surg Oncol. 1999 Jun;71(2):106-11. — View Citation

Saliken JC, Donnelly BJ, Rewcastle JC. The evolution and state of modern technology for prostate cryosurgery. Urology. 2002 Aug;60(2 Suppl 1):26-33. Review. — View Citation

Sanderson DR, Neel HB 3rd, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981 Jul-Aug;90(4 Pt 1):354-8. — 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

* Note: There are 38 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Percentage of Participants Who Respond to the Cryoablation Therapy Response was defined as a =2-point reduction from baseline in worst pain in last 24 hours with stable medication use (that is, no more than a 25% increase in Morphine Equivalent Daily Dose [MEDD] from baseline). MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Pain was assessed using BPI-SF with a scale of 0 (no pain) to 10 (worst pain imaginable). Percentages are proportion of responders based on logistic regression after MCMC, multiple imputation. For visits where medication use is not available, morphine equivalent values from the most recent non-missing visit are used. Baseline and Week 8
Other Change From Baseline in QoL as Indicated by the Overall Average BPI-SF Interference Score at Weeks 1, 4, 8, 12, 16, 20, and 24. Quality of Life (QoL) as indicated by the change in overall average BPI-SF Pain Interference score from baseline to each visit was evaluated at Weeks 1, 4, 8, 12, 16, 20, and 24. Using the BPI-SF, participants rated the amount of interference from pain on a scale of 0 (does not interfere) to 10 (completely interferes) for the following areas: general activity. mood, walking ability, relations, sleep, and enjoyment. For participants with responses =50% of the areas at a time point, a total Pain Interference score, which was the mean of the individual area scores, was calculated programmatically at that point. Baseline data and change from Baseline data is presented. Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24 The Karnofsky Performance Status (KPS) scale is a standard way of measuring the ability of cancer participants to perform ordinary tasks. KPS may be used to determine a participant's prognosis and to measure changes in a participant's ability to function. Assessments made by examining the change in the baseline scores to those reported post-operatively. KPS scores range from 0 to 100. A higher score means the participant is better able to carry out daily activities from Baseline to 1, 4, 8, 12, 16, 20, and 24 weeks after cryoablation. Baseline data and change from Baseline data is presented. Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Number of Participants With Additional Pain Therapies Participants requiring additional targeted therapies to the index tumor (for example, cryoablation, radio frequency ablation [RFA], microwave ablation [MWA], high intensity focused ultrasound [HIFU], radiation, surgery) were withdrawn from the study. Other therapies, including pain medication and chemotherapy, were permitted during the study. All additional therapies were recorded. The number of participants requiring new therapy since the last visit is presented. Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24 Analgesic (that is, opioid or non-steroidal anti-inflammatory drug [NSAID]) use and the reason for each change in analgesic dose was recorded at each study visit. Opioid medications were converted to a standardized MEDD. MEDD is calculated using the following formula: [Dose]*[MEDD Factor]. MEDD Factor is based on the type and dose of the opioid received. Baseline data and change from Baseline data is presented. Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24 The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by =2-point reduction in worst pain. A mean difference of a 2 point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Weeks 1, 4, 12, 16, 20, and 24 is presented. Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24
Other Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24 The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported average pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Baseline data and change from Baseline data is presented. Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24 Participants performed a self-assessment of OTE at Week 1 and every visit thereafter (Weeks 4, 8, 12, 16, 20 and 24). Participants were asked their opinion of the effect cryoablation procedure had on their wellbeing and asked to compare their wellbeing at the time of each follow-up visit to the previous visit or phone call. The wellbeing categories were "Better than the Last Visit," "The Same as the Last Visit," and "Worse than the Last Visit." The percentage of participants that were reported for each wellbeing category at Weeks 1, 4, 8, 12, 16, 20, and 24 is presented. Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Other Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects The number of participants with an intra-operative non-serious adverse event, a post-operative, a non-serious adverse event, a serious adverse event, or unanticipated adverse device effects related to the cryoablation procedure is presented. A summary of serious and all other non-serious adverse events, regardless of causality, is located in the Reported Adverse Events module. Baseline up to 30 days post-cryoablation
Primary Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8 The BPI-SF is a validated instrument used widely in clinical research to assess cancer pain. Assessments were of self-reported worst pain scores in the last 24 hours in the target lesion treated with study cryoablation on a scale from 0 (no pain) to 10 (worst pain imaginable) using the BPI-SF. Improvement in self-reported pain scores is defined by =2-point reduction in worst pain. A mean difference of a 2-point reduction is considered clinically significant, that is improvement. Baseline data and change from Baseline data at Week 8 is presented. Baseline, Week 8
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