search
Back to results

Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases (MOTION)

Primary Purpose

Pain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Cryoablation
Sponsored by
Boston Scientific Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Ronald Reagan Medical Center
  • Emory University Hospital
  • Massachusetts General Hospital
  • Crittenton Hospital
  • Mayo Clinic Rochester
  • Washington University in St. Louis
  • Rhode Island Hospital
  • Institut Bergonié
  • Centre Léon Bérard
  • University Hospital of Strasbourg
  • Institut Gustave Roussy

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cryoablation

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
July 27, 2015
Last Updated
July 15, 2021
Sponsor
Boston Scientific Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT02511678
Brief Title
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Acronym
MOTION
Official Title
Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
February 15, 2016 (Actual)
Primary Completion Date
March 12, 2018 (Actual)
Study Completion Date
March 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Scientific Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cryoablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Cryoablation
Other Intervention Name(s)
Cryotherapy, Cryosurgery, Visual-ICE™ Cryoablation System, IceSeed® Cryoablation Needle, IceSphere™ Cryoablation Needle, IceRod® PLUS Cryoablation Needle, IceEDGE® 2.4 Cryoablation Needle, IceFORCE® 2.1 Cryoablation Needle, IcePearl® 2.1 Cryoablation Needle
Intervention Description
The application of repeated freeze and thaw cycles to the identified tissues.
Primary Outcome Measure Information:
Title
Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8
Description
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.
Time Frame
Baseline, Week 8
Other Pre-specified Outcome Measures:
Title
Percentage of Participants Who Respond to the Cryoablation Therapy
Description
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.
Time Frame
Baseline and Week 8
Title
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.
Description
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.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Number of Participants With Additional Pain Therapies
Description
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.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Week 1, Week 4, Week 12, Week 16, Week 20, and Week 24
Title
Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24
Description
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.
Time Frame
Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24
Description
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.
Time Frame
Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24
Title
Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects
Description
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.
Time Frame
Baseline up to 30 days post-cryoablation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack Jennings, MD
Organizational Affiliation
Washington University Saint Louis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Ronald Reagan Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Crittenton Hospital
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University in St. Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Institut Bergonié
City
Bordeaux
ZIP/Postal Code
33000
Country
France
Facility Name
Centre Léon Bérard
City
Lyon
ZIP/Postal Code
69373
Country
France
Facility Name
University Hospital of Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Institut Gustave Roussy
City
Villejuif
ZIP/Postal Code
94805
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
1387912
Citation
Goldfarb HA. Nd:YAG laser laparoscopic coagulation of symptomatic myomas. J Reprod Med. 1992 Jul;37(7):636-8.
Results Reference
background
PubMed Identifier
9224575
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. doi: 10.1016/s1074-3804(05)80034-9.
Results Reference
background
PubMed Identifier
8786884
Citation
Goldfarb HA. Laparoscopic coagulation of myoma (myolysis). Obstet Gynecol Clin North Am. 1995 Dec;22(4):807-19. No abstract available.
Results Reference
background
PubMed Identifier
13881139
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. No abstract available.
Results Reference
background
PubMed Identifier
12206845
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. doi: 10.1016/s0090-4295(02)01681-3.
Results Reference
background
PubMed Identifier
10389867
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. doi: 10.1002/(sici)1096-9098(199906)71:23.0.co;2-z.
Results Reference
background
PubMed Identifier
9354166
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. doi: 10.1002/(sici)1096-9098(199710)66:23.0.co;2-g.
Results Reference
background
PubMed Identifier
3197439
Citation
Gage AA. Current progress in cryosurgery. Cryobiology. 1988 Oct;25(5):483-6. doi: 10.1016/0011-2240(88)90056-9.
Results Reference
background
PubMed Identifier
3979086
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. doi: 10.1016/0011-2240(85)90172-5.
Results Reference
background
PubMed Identifier
1582235
Citation
Gage AA. Progress in cryosurgery. Cryobiology. 1992 Apr;29(2):300-4. doi: 10.1016/0011-2240(92)90030-6.
Results Reference
background
PubMed Identifier
8050273
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. doi: 10.1006/cryo.1994.1035.
Results Reference
background
PubMed Identifier
8263903
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. doi: 10.3109/03091909309016215.
Results Reference
background
PubMed Identifier
9181244
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.
Results Reference
background
PubMed Identifier
8812089
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. doi: 10.1006/cryo.1996.0010.
Results Reference
background
PubMed Identifier
2992882
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. doi: 10.1016/0011-2240(85)90178-6.
Results Reference
background
PubMed Identifier
971585
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. doi: 10.1016/0011-2240(76)90096-1.
Results Reference
background
PubMed Identifier
19833119
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.
Results Reference
background
PubMed Identifier
18070688
Citation
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.
Results Reference
background
PubMed Identifier
18070690
Citation
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.
Results Reference
background
PubMed Identifier
10796822
Citation
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.
Results Reference
background
PubMed Identifier
17057075
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. doi: 10.1148/radiol.2412051247.
Results Reference
background
PubMed Identifier
11110597
Citation
Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
Results Reference
background
PubMed Identifier
14722039
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, 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.
Results Reference
background
PubMed Identifier
12091666
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. doi: 10.1148/radiol.2241011613.
Results Reference
background
PubMed Identifier
18695866
Citation
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.
Results Reference
background
PubMed Identifier
24760791
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):dju082. doi: 10.1093/jnci/dju082.
Results Reference
background
PubMed Identifier
16598666
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. doi: 10.1055/s-2006-939031. Epub 2006 Apr 5.
Results Reference
background
PubMed Identifier
18054665
Citation
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.
Results Reference
background
PubMed Identifier
10431856
Citation
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.
Results Reference
background
PubMed Identifier
8521698
Citation
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.
Results Reference
background
PubMed Identifier
6791555
Citation
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.
Results Reference
background
PubMed Identifier
8996403
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.
Results Reference
background
PubMed Identifier
6024400
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. No abstract available.
Results Reference
background
PubMed Identifier
513700
Citation
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.
Results Reference
background
PubMed Identifier
10399979
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.
Results Reference
background
PubMed Identifier
6034857
Citation
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.
Results Reference
background
PubMed Identifier
23065947
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.
Results Reference
background
PubMed Identifier
17062707
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. doi: 10.1158/1078-0432.CCR-06-0988.
Results Reference
background
PubMed Identifier
33817650
Citation
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.
Results Reference
derived

Learn more about this trial

Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

We'll reach out to this number within 24 hrs