Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

NCT02511678 | Completed Results

• 1 other identifier: CGC15-BNE098
• Study Type: interventional
• Target: 73
• Locations: 2 countries
• Sites: 11

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).

Conditions

Pain; Neoplasm Metastasis; Bone Metastasis of Diverse Origins

Outcome Measures

Primary Outcomes (1)

• 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

Other Outcomes (9)

• Percentage of Participants Who Respond to the Cryoablation Therapy

  Baseline and Week 8

• 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.

  Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

• Change From Baseline in Physical Function as Assessed by the KPS Scale at Weeks 1, 4, 8, 12, 16, 20, and 24

  Baseline, Week 1, Week 4, Week 8, Week 12, Week 16, Week 20, and Week 24

Study Arms (1)

Cryoablation

EXPERIMENTAL

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.

Device: Cryoablation

Interventions

Cryoablation DEVICE

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

Also known as: 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

Cryoablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boston Scientific Corporation: lead

Study Sites (11)

UCLA Ronald Reagan Medical Center

Los Angeles, California, 90095, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Crittenton Hospital

Rochester, Michigan, 48307, United States

Location

Mayo Clinic Rochester

Rochester, Minnesota, 55905, United States

Location

Washington University in St. Louis

St Louis, Missouri, 63110, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

Institut Bergonié

Bordeaux, 33000, France

Location

Centre Léon Bérard

Lyon, 69373, France

Location

University Hospital of Strasbourg

Strasbourg, 67091, France

Location

Institut Gustave Roussy

Villejuif, 94805, France

Location

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MeSH Terms

Conditions

Pain; Neoplasm Metastasis

Interventions

Cryosurgery; Cryotherapy

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Neoplasms; Pathologic Processes

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative; Therapeutics

Results Point of Contact

• Title: Sr. Clinical Trial Specialist
• Organization: Galil Medical, a wholly owned indirect subsidiary of Boston Scientific

GalilClinical@bsci.com

651-287-5000

Study Officials

• Jack Jennings, MD

  Washington University Saint Louis

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2015
• First Posted: July 30, 2015
• Study Start: February 15, 2016
• Primary Completion: March 12, 2018
• Study Completion: March 12, 2018
• Last Updated: July 19, 2021
• Results First Posted: September 4, 2019

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (4); US (7)