Neoplasms

Symptoms and General Pathology

All Conditions

Musculoskeletal Diseases

Blood and Lymph Conditions

Neoplasm Metastasis

Pain

Neoplasms, Second Primary

Bone Neoplasms

Bone Marrow Diseases

Neoplastic Processes

Bone Diseases

Hematologic Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

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.

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

Cryoablation

Jack Jennings, MD

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).

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.

Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Boston Scientific Corporation

All-Cause Mortality reported for all Enrolled Participants. Adverse Events were monitored and reported for participants who received the complete study cryoablation procedure (Safety Population \[N=65\]).

All participants had 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 was selected for cryoablation. If treatment could not be completed within 14 days of screening, the participant was re-screened using the inclusion and exclusion criteria. Participant preparation, anesthesia, intra-operative monitoring, and postoperative management for the study cryoablation procedure were identical to those for standard cryoablation treatment routinely performed at the clinical centers that participated in this study and were at the discretion of the Investigators.

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population).

Sr. Clinical Trial Specialist

Baseline

Change at Week 8

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population). The Markov chain Monte Carlo (MCMC) method of imputation was used for imputation of missing BPI-SF values with 50 imputations to be performed.

Change From Baseline in Worst Pain Scores as Assessed by the Brief Pain Inventory-Short Form (BPI-SF) at Week 8

Percentage of Participants Who Respond to the Cryoablation Therapy

General Activity, Baseline

General Activity, Change at Week 1

General Activity, Change at Week 4

General Activity, Change at Week 8

General Activity, Change at Week 12

General Activity, Change at Week 16

General Activity, Change at Week 20

General Activity, Change at Week 24

Mood, Baseline

Mood, Change at Week 1

Mood, Change at Week 4

Mood, Change at Week 8

Mood, Change at Week 12

Mood, Change at Week 16

Mood, Change at Week 20

Mood, Change at Week 24

Walking Ability, Baseline

Walking Ability, Change at Week 1

Walking Ability, Change at Week 4

Walking Ability, Change at Week 8

Walking Ability, Change at Week 12

Walking Ability, Change at Week 16

Walking Ability, Change at Week 20

Walking Ability, Change at Week 24

Normal Work, Baseline

Normal Work, Change at Week 1

Normal Work, Change at Week 4

Normal Work, Change at Week 8

Normal Work, Change at Week 12

Normal Work, Change at Week 16

Normal Week, Change at Week 20

Normal Week, Change at Week 24

Relations, Baseline

Relations, Change at Week 1

Relations, Change at Week 4

Relations, Change at Week 8

Relations, Change at Week 12

Relations, Change at Week 16

Relations, Change at Week 20

Relations, Change at Week 24

Sleep, Baseline

Sleep, Change at Week 1

Sleep, Change at Week 4

Sleep, Change at Week 8

Sleep, Change at Week 12

Sleep, Change at Week 16

Sleep, Change at Week 20

Sleep, Change at Week 24

Enjoyment, Baseline

Enjoyment, Change at Week 1

Enjoyment, Change at Week 4

Enjoyment, Change at Week 8

Enjoyment, Change at Week 12

Enjoyment, Change at Week 16

Enjoyment, Change at Week 20

Enjoyment, Change at Week 24

Total Pain, Baseline

Total Pain, Change at Week 1

Total Pain, Change at Week 4

Total Pain, Change at Week 8

Total Pain, Change at Week 12

Total Pain, Change at Week 16

Total Pain, Change at Week 20

Total Pain, Change at Week 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable interference from pain scores.

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.

Change at Week 1

Change at Week 4

Change at Week 12

Change at Week 16

Change at Week 20

Change at Week 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable KPS scores.

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

Week 1

Week 4

Week 8

Week 12

Week 16

Week 20

Week 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable additional pain therapy data.

Number of Participants With Additional Pain Therapies

MEDD, Baseline

MEDD, Change at Week 1

MEDD, Change at Week 4

MEDD, Change at Week 8

MEDD, Change at Week 12

MEDD, Change at Week 16

MEDD, Change at Week 20

MEDD, Change at Week 24

NSAID, Baseline

NSAID, Change at Week 1

NSAID, Change at Week 4

NSAID, Change at Week 8

NSAID, Change at Week 12

NSAID, Change at Week 16

NSAID, Change at Week 20

NSAID, Change at Week 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable MEDD and NSAID data.

Change From Baseline in MEDD and NSAID Doses at Weeks 1, 4, 8, 12, 16, 20, and 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable worse pain scores.

Change From Baseline in Worst Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 12, 16, 20, and 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable average pain scores.

Change From Baseline in Average Pain Scores as Assessed by the BPI-SF at Weeks 1, 4, 8, 12, 16, 20, and 24

Better than the Last Visit, Week 1

Better than the Last Visit, Week 4

Better than the Last Visit, Week 8

Better than the Last Visit, Week 12

Better than the Last Visit, Week 16

Better than the Last Visit, Week 20

Better than the Last Visit, Week 24

Same as the Last Visit, Week 1

Same as the Last Visit, Week 4

Same as the Last Visit, Week 8

Same as the Last Visit, Week 12

Same as the Last Visit, Week 16

Same as the Last Visit, Week 20

Same as the Last Visit, Week 24

Worse than the Last Visit, Week 1

Worse than the Last Visit, Week 4

Worse than the Last Visit, Week 8

Worse than the Last Visit, Week 12

Worse than the Last Visit, Week 16

Worse than the Last Visit, Week 20

Worse than the Last Visit, Week 24

Missing, Week 1

Missing, Week 4

Missing, Week 8

Missing, Week 12

Missing, Week 16

Missing, Week 20

Missing, Week 24

Participants for whom cryoablation via a Galil Medical cryoablation system was attempted or performed (ITT Population) and evaluable OTE data.

Self-Assessed Overall Treatment Effect (OTE) at Weeks 1, 4, 8, 12, 16, 20, and 24

Intra-operative non-serious adverse event

Post-operative non-serious adverse event

Non-serious event after discharge within 30 days

Serious adverse event

Unanticipated adverse device effect

Participants for whom received the complete study cryoablation procedure (Safety Population).

Number of Participants With Intra- or Post-operative Adverse Events, a Serious Adverse Event, or Unanticipated Adverse Device Effects

Overall Study

Spots Global Cancer Trial Database for Multicenter Study of Cryoablation for Palliation of Painful Bone Metastases

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial