Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Completed · Not applicable

Conditions studied: Pain, Neoplasm Metastasis, Bone Metastasis of Diverse Origins

In brief

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).

Key facts

Study ID: NCT02511678
Run by: Boston Scientific Corporation
People needed: 73
Starts: 2016-02-15
Expected to finish: 2018-03-12
Last updated by the study team: 2021-07-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

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

Where it is running

UCLA Ronald Reagan Medical Center — Los Angeles, California, United States
Emory University Hospital — Atlanta, Georgia, United States
Massachusetts General Hospital — Boston, Massachusetts, United States
Crittenton Hospital — Rochester, Michigan, United States
Mayo Clinic Rochester — Rochester, Minnesota, United States
Washington University in St. Louis — St Louis, Missouri, United States
Rhode Island Hospital — Providence, Rhode Island, United States
Institut Bergonié — Bordeaux, France
Centre Léon Bérard — Lyon, France
University Hospital of Strasbourg — Strasbourg, France
Institut Gustave Roussy — Villejuif, France

Full record on ClinicalTrials.gov

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