Safety and Efficacy of Cryoablation for the Palliation of Painful Bone Metastases

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

29 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2015-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Cryoablation for Post Mastectomy Pain Syndrome

NCT03293940

Post-Mastectomy Chronic Pain Syndrome (Disorder)

COMPLETED NA

Potential Vertebroplasty Use in the Treatment of Vertebral Metastasis From Breast and Prostate Cancer

NCT00294151

Breast Cancer Prostate Cancer Vertebral Metastasis +1 more

UNKNOWN PHASE3

Comparison of Microwave Ablation With Cryoablation for Breast Tumor

NCT03286413

Breast Tumor Microwave Ablation Cryoablation

UNKNOWN NA

BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe

NCT06480955

Bone Metastases

RECRUITING

Bone Pain Score Validation Initiative

NCT02293642

Bone Metastasis

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with painful bone metastases who meet the eligibility criteria and who have been determined to be an appropriate candidate for cryoablation 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).

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pain Neoplasm Metastasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cryoablation

All subjects will have cryoablation on one or two painful metastatic bone tumors.

Group Type OTHER

Cryoablation

Intervention Type PROCEDURE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cryoablation

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.

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cryotherapy Cryosurgery Visual-ICE Cryoablation System SeedNet Cryoablation System PresIce Cryoablation System IceRod Cryoablation Needle IceRod PLUS Cryoablation Needle IceEDGE 2.4 Cryoablation Needle IceSeed Cryoablation Needle IceSphere Cryoablation Needle

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
* Tumors must be suitable for cryoablation
* 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 screening
* INR (International Normalized Ratio) \<1.5 within 6 weeks 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

Exclusion Criteria

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No