PainPhase 1NCT01461252

Safety and Efficacy of Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

A Phase 1 study testing Cryoablation and Radiation in people with Pain and Neoplasm Metastasis, run by Boston Scientific Corporation.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

Search all trials

Trial summary

This study will evaluate the safety and efficacy of cryoablation therapy combined with radiation therapy for the relief of pain associated with metastatic bone tumors. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Pain, Neoplasm Metastasis
What is being tested?: Cryoablation and Radiation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Apr 2013to Mar 2014
Phase: Phase 1
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 19Show fewer

Tumors must be suitable for cryoablation
If the primary tumor is in the spine, there must be an intact cortex between the mass and the spinal canal and exiting nerve roots
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 of screening
INR (International Normalized Ratio) <1.5 within 6 weeks of 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
Clinically suitable for radiation therapy

Who cannot join

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
Has undergone 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

Show all 14Show fewer

Surgery at the tumor site or surgery involving the cryoablation-treated tumor
Index tumor involves the skull (treatment of other painful tumors in subjects with skull tumors is not excluded)
ANC (absolute neutrophil count) <1000 mm3 within 6 weeks of 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

About this study

Official title: Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases

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

Read the 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 and radiation 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). Radiation therapy, also called radiotherapy, uses carefully targeted doses of high-energy radiation to kill cancer cells. Radiation is used to treat many kinds of cancer.

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.

Conditions: Pain, Neoplasm Metastasis
Being tested: Cryoablation, Radiation
Keywords: Painful bone metastases, Bone metastases, Metastatic bone tumors, Metastatic bone pain, Cryoablation, Cryotherapy, Cryosurgery, Radiation therapy, Radiotherapy
Medical subject headings: Pain, Neoplasm Metastasis, Bone Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CryoablationProcedure or surgery
Also called Cryotherapy, Cryosurgery, Visual-ICE Cryoabltaion System, SeedNet Cryoablation System
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.
RadiationProcedure or surgery
Also called Radiotherapy
Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.

Study groups in NCT01461252
Study group	Role	What they receive
Cryoablation combined with radiation	Other	All subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors. Receives: Procedure: Cryoablation; Procedure: Radiation

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in worst pain scores
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation 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.
Measured: 24 weeks post cryoablation

Secondary outcomes (8)

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.
Measured: 24 weeks post-cryoablation
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.
Measured: 24 weeks post-cryoablation
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.
Measured: 24 weeks post-cryoablation
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.
Measured: 24 weeks post-cryoablation
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.
Measured: 30 days post-cryoablation
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
Measured: 24 weeks post-cryoablation
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
Measured: 24 weeks post-cryoablation
Subject satisfaction with the amount of palliation of pain obtained from cryoablation combined with radiation
Subject satisfaction will be compared at baseline to follow-up intervals.
Measured: 24 weeks post-cryoablation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013Mar 2014

First posted28 Oct 2011 (estimated)
Study startApr 2013
Primary completionMar 2014
Study completionMar 2014

Why it stopped: No patients were treated due to enrollment challenges.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for PainStudies of the same condition, open and under way.
More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01461252
Sponsor's protocol ID: CUC10-BNE01
Status last verified: Jul 2021
First submitted: 25 Oct 2011
Last updated: 16 Jul 2021
Results posted: No
Data monitoring committee: No

Publications

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.
PubMed 18070690
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.
PubMed 10796822
Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007 Apr 10;25(11):1423-36. doi: 10.1200/JCO.2006.09.5281.
PubMed 17416863
Fairchild A, Barnes E, Ghosh S, Ben-Josef E, Roos D, Hartsell W, Holt T, Wu J, Janjan N, Chow E. International patterns of practice in palliative radiotherapy for painful bone metastases: evidence-based practice? Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1501-10. doi: 10.1016/j.ijrobp.2008.12.084. Epub 2009 May 21.
PubMed 19464820
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.
PubMed 17057075
Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
PubMed 11110597
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.
PubMed 18695866
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.
PubMed 16598666
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.
PubMed 18054665
Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
PubMed 15928300
Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
PubMed 12573746
Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989-97. doi: 10.1002/cncr.24837.
PubMed 20041484
Callstrom MR, York JD, Gaba RC, Gemmete JJ, Gervais DA, Millward SF, Brown DB, Dupuy D, Goldberg SN, Kundu S, Rose SC, Thomas JJ, Cardella JF; Technology Assessment Committee of Society of Interventional Radiology. Research reporting standards for image-guided ablation of bone and soft tissue tumors. J Vasc Interv Radiol. 2009 Dec;20(12):1527-40. doi: 10.1016/j.jvir.2009.08.009. Epub 2009 Oct 27. No abstract available.
PubMed 19864161

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 16 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cryoablation Combined With Radiation Therapy for the Palliation of Painful Bone Metastases
ClinicalTrials.gov ID: NCT01461252
Acronym / sponsor ID: CUC10-BNE01
Conditions: Pain, Neoplasm Metastasis
Keywords: Painful bone metastases, Bone metastases, Metastatic bone tumors, Metastatic bone pain, Cryoablation, Cryotherapy, Cryosurgery, Radiation therapy
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: No patients were treated due to enrollment challenges.
Enrolment: 0 participants (actual)
Lead sponsor: Boston Scientific CorporationIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 28 Oct 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Cryoablation combined with radiation	Other	Procedure: Cryoablation, Procedure: RadiationAll subjects will have cryoablation combined with radiation on one or two painful metastatic bone tumors.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (19 listed)

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)

Key exclusion criteria (14 listed)

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
Has undergone 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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CryoablationAlso: Cryotherapy, Cryosurgery, Visual-ICE Cryoabltaion System, SeedNet Cryoablation SystemFor 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.	Procedure or surgery	Cryoablation combined with radiation
RadiationAlso: RadiotherapyRadiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.	Procedure or surgery	Cryoablation combined with radiation

Primary outcome

Difference in worst pain scores
Time frame: 24 weeks post cryoablation
The endpoint for this study will be measured as follows: assessment of the effectiveness of cryoablation combined with radiation 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.

8 secondary outcomes

Cryoablation retreatments
Time frame: 24 weeks post-cryoablation
Additional surgical treatments other than cryoablation
Time frame: 24 weeks post-cryoablation
Reduced analgesic usage
Time frame: 24 weeks post-cryoablation
Time to maximal palliation of pain after cryoablation
Time frame: 24 weeks post-cryoablation
Number of adverse events
Time frame: 30 days post-cryoablation
Difference in average pain scores
Time frame: 24 weeks post-cryoablation
Time to recurrence of worst pain
Time frame: 24 weeks post-cryoablation
Subject satisfaction with the amount of palliation of pain obtained from cryoablation combined with radiation
Time frame: 24 weeks post-cryoablation

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2021.
Background: PubMed 18070690Callstrom 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.
Background: PubMed 10796822McQuay 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.
Background: PubMed 17416863Chow E, Harris K, Fan G, Tsao M, Sze WM. Palliative radiotherapy trials for bone metastases: a systematic review. J Clin Oncol. 2007 Apr 10;25(11):1423-36. doi: 10.1200/JCO.2006.09.5281.
Background: PubMed 19464820Fairchild A, Barnes E, Ghosh S, Ben-Josef E, Roos D, Hartsell W, Holt T, Wu J, Janjan N, Chow E. International patterns of practice in palliative radiotherapy for painful bone metastases: evidence-based practice? Int J Radiat Oncol Biol Phys. 2009 Dec 1;75(5):1501-10. doi: 10.1016/j.ijrobp.2008.12.084. Epub 2009 May 21.
Background: PubMed 17057075Callstrom 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.
Background: PubMed 11110597Coleman RE. Management of bone metastases. Oncologist. 2000;5(6):463-70. doi: 10.1634/theoncologist.5-6-463.
Background: PubMed 18695866Belfiore 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.
Background: PubMed 16598666Simon 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.
Background: PubMed 18054665Ullrick 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.
Background: PubMed 15928300Hartsell WF, Scott CB, Bruner DW, Scarantino CW, Ivker RA, Roach M 3rd, Suh JH, Demas WF, Movsas B, Petersen IA, Konski AA, Cleeland CS, Janjan NA, DeSilvio M. Randomized trial of short- versus long-course radiotherapy for palliation of painful bone metastases. J Natl Cancer Inst. 2005 Jun 1;97(11):798-804. doi: 10.1093/jnci/dji139.
Background: PubMed 12573746Wu JS, Wong R, Johnston M, Bezjak A, Whelan T; Cancer Care Ontario Practice Guidelines Initiative Supportive Care Group. Meta-analysis of dose-fractionation radiotherapy trials for the palliation of painful bone metastases. Int J Radiat Oncol Biol Phys. 2003 Mar 1;55(3):594-605. doi: 10.1016/s0360-3016(02)04147-0.
Background: PubMed 20041484Dupuy DE, Liu D, Hartfeil D, Hanna L, Blume JD, Ahrar K, Lopez R, Safran H, DiPetrillo T. Percutaneous radiofrequency ablation of painful osseous metastases: a multicenter American College of Radiology Imaging Network trial. Cancer. 2010 Feb 15;116(4):989-97. doi: 10.1002/cncr.24837.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jerry Matteo, MD study chair

Shands Medical Center, Jacksonville, FL

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cryoablation and Radiation in people with Pain and Neoplasm Metastasis, run by Boston Scientific Corporation.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 16 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in worst pain scores (time frame: 24 weeks post cryoablation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01461252, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2021.