- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02511678
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (MOTION)
July 15, 2021 updated by: Boston Scientific Corporation
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).
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
73
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Bordeaux, France, 33000
- Institut Bergonié
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Lyon, France, 69373
- Centre Leon Bérard
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Strasbourg, France, 67091
- University Hospital of Strasbourg
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Villejuif, France, 94805
- Institut Gustave Roussy
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California
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Los Angeles, California, United States, 90095
- UCLA Ronald Reagan Medical Center
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory University Hospital
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Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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Michigan
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Rochester, Michigan, United States, 48307
- Crittenton Hospital
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic Rochester
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Missouri
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Saint Louis, Missouri, United States, 63110
- Washington University in St. Louis
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Rhode Island
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Providence, Rhode Island, United States, 02903
- Rhode Island Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cryoablation
All participants will have one cryoablation procedure on one painful metastatic lesion involving bone using a Galil Medical cryoablation system and needles within 14 days of screening.
In the case of participants with multiple metastatic lesions involving bone, the most painful lesion is to be selected for cryoablation.
If treatment could not be completed within 14 days of screening, the participant will be re-screened using the inclusion and exclusion criteria.
Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure will be identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and will be at the discretion of the Investigators.
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The application of repeated freeze and thaw cycles to the identified tissues.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
Time Frame: Baseline, Week 8
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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.
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Baseline, Week 8
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Percentage of Participants Who Respond to the Cryoablation Therapy
Time Frame: Baseline and Week 8
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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.
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Baseline and Week 8
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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.
Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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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.
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Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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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.
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Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Number of Participants With Additional Pain Therapies
Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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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.
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Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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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.
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Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Time Frame: Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24
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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.
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Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24
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Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Time Frame: Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 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.
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Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Time Frame: Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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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.
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Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
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Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Time Frame: Baseline up to 30 days post-cryoablation
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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.
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Baseline up to 30 days post-cryoablation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jack Jennings, MD, Washington University Saint Louis
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.
- 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. doi: 10.1016/s0090-4295(02)01681-3.
- 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. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.
- 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. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.
- Callstrom MR, Charboneau JW. Image-guided palliation of painful metastases using percutaneous ablation. Tech Vasc Interv Radiol. 2007 Jun;10(2):120-31. doi: 10.1053/j.tvir.2007.09.003.
- McQuay HJ, Collins SL, Carroll D, Moore RA. Radiotherapy for the palliation of painful bone metastases. Cochrane Database Syst Rev. 2000;(2):CD001793. doi: 10.1002/14651858.CD001793.
- 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. doi: 10.1148/radiol.2412051247.
- Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
- 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.
- 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. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.
- Ullrick SR, Hebert JJ, Davis KW. Cryoablation in the musculoskeletal system. Curr Probl Diagn Radiol. 2008 Jan-Feb;37(1):39-48. doi: 10.1067/j.cpradiol.2007.05.001.
- 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. doi: 10.1148/radiol.2241011613.
- 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.
- 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, Gronemeyer 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. doi: 10.1200/JCO.2004.03.097.
- Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
- 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. doi: 10.1016/s1074-3804(05)80034-9.
- 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. No abstract available.
- Gage AA. Current progress in cryosurgery. Cryobiology. 1988 Oct;25(5):483-6. doi: 10.1016/0011-2240(88)90056-9.
- 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. doi: 10.1016/0011-2240(85)90172-5.
- Gage AA. Progress in cryosurgery. Cryobiology. 1992 Apr;29(2):300-4. doi: 10.1016/0011-2240(92)90030-6.
- 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. doi: 10.1006/cryo.1994.1035.
- 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. doi: 10.3109/03091909309016215.
- Rabin Y, Julian TB, Wolmark N. A compact cryosurgical apparatus for minimally invasive procedures. Biomed Instrum Technol. 1997 May-Jun;31(3):251-8.
- Rabin Y, Coleman R, Mordohovich D, Ber R, Shitzer A. A new cryosurgical device for controlled freezing. Cryobiology. 1996 Feb;33(1):93-105. doi: 10.1006/cryo.1996.0010.
- 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. doi: 10.1016/0011-2240(85)90178-6.
- 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. doi: 10.1016/0011-2240(76)90096-1.
- 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.
- McTaggart RA, Dupuy DE. Thermal ablation of lung tumors. Tech Vasc Interv Radiol. 2007 Jun;10(2):102-13. doi: 10.1053/j.tvir.2007.09.004.
- 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):dju082. doi: 10.1093/jnci/dju082.
- Maiwand MO. The role of cryosurgery in palliation of tracheo-bronchial carcinoma. Eur J Cardiothorac Surg. 1999 Jun;15(6):764-8. doi: 10.1016/s1010-7940(99)00121-9.
- Maiwand MO, Homasson JP. Cryotherapy for tracheobronchial disorders. Clin Chest Med. 1995 Sep;16(3):427-43. Erratum In: Clin Chest Med 1995 Dec;16(4):ix.
- Sanderson DR, Neel HB 3rd, Fontana RS. Bronchoscopic cryotherapy. Ann Otol Rhinol Laryngol. 1981 Jul-Aug;90(4 Pt 1):354-8. doi: 10.1177/000348948109000414.
- 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.
- 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. No abstract available.
- Gage AM, Montes M, Gage AA. Freezing the canine thoracic aorta in situ. J Surg Res. 1979 Nov;27(5):331-40. doi: 10.1016/0022-4804(79)90149-5. No abstract available.
- 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.
- Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels. Laryngoscope. 1967 Aug;77(8):1328-50. doi: 10.1288/00005537-196708000-00009. No abstract available.
- 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. doi: 10.1158/1078-0432.CCR-06-0988.
- Jennings JW, Prologo JD, Garnon J, Gangi A, Buy X, Palussiere J, Kurup AN, Callstrom M, Genshaft S, Abtin F, Huang AJ, Iannuccilli J, Pilleul F, Mastier C, Littrup PJ, de Baere T, Deschamps F. Cryoablation for Palliation of Painful Bone Metastases: The MOTION Multicenter Study. Radiol Imaging Cancer. 2021 Feb 12;3(2):e200101. doi: 10.1148/rycan.2021200101. eCollection 2021 Mar.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 15, 2016
Primary Completion (Actual)
March 12, 2018
Study Completion (Actual)
March 12, 2018
Study Registration Dates
First Submitted
July 27, 2015
First Submitted That Met QC Criteria
July 29, 2015
First Posted (Estimate)
July 30, 2015
Study Record Updates
Last Update Posted (Actual)
July 19, 2021
Last Update Submitted That Met QC Criteria
July 15, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CGC15-BNE098
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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