Clinical trial · Interventional
Percutaneous Cryoablation in Treating Patients With Painful Bone Metastases
Percutaneous US and CT-guided Cryoablation of Painful Metastases Involving Bone: A Feasibility Study
NCT00608855CI-TRIAL-00025467completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Percutaneous cryoablation may help relieve pain caused by bone metastases. PURPOSE: This clinical trial is studying the side effects and how well percutaneous cryoablation works in treating patients with painful bone metastases.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Cancer | Malignant Neoplasm | CURATED_BROADER | 0.78 |
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cryosurgery | Procedure | — | UNRESOLVED |
| pain therapy | Procedure | — | UNRESOLVED |
| quality-of-life assessment | Procedure | — | UNRESOLVED |
| questionnaire administration | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Average difference in pre- and post-treatment worst pain score in a 24-hour period at week 8
Secondary outcomes (3)
- measure
- Average difference in pre- and post-treatment worst pain score in a 24-hour period, average pain score, and pain relief score at 6, 12, and 24 months
- measure
- Average amount of pain per patient over the observation period as represented by the area under the curve (AUC) constructed from weekly pain scores on a visual-analogue scale using a score of 0-10
- measure
- Percentage of patients who are able to reduce analgesic medications
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 120 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed metastatic solid tumor involving or abutting bone (index lesion) * If the nature of the metastatic disease has been previously documented, index lesion to be treated does not require further documentation (i.e., biopsy) * Pain either refractory to standard care (chemotherapy, radiotherapy, surgery, or analgesics) or patient is considered a poor candidate for conventional therapies * Radiation oncology consult is required if the patient is considered clinically to be a candidate for conventional palliative radiotherapy * Surgical oncology consult is required if the patient is considered clinically to be a candidate for conventional surgical treatment or is considered at risk for complications resulting from potential fracture * Initial pain score ≥ 4 on a scale of 0-10 for the question "Please rate your pain by circling the one number that best describes your pain at its worst in the past 24 hours" on the Cleeland Brief Pain Inventory * Pain from ≤ 2 sites of metastatic disease * No lesions with evidence for impending fracture involving a weight-bearing bone (\> 50% loss of cortical bone at the site) PATIENT CHARACTERISTICS: * Life expectancy ≥ 2 months * Platelet count ≥ 75,000/mm³ * ANC \> 1,500/mm³ (for patients who have recently been treated with chemotherapy) * INR ≤ 1.2 * Not pregnant or nursing * Negative pregnancy test PRIOR CONCURRENT THERAPY: * More than 3 weeks since prior radiotherapy * More than 3 weeks since initiation of a new chemotherapy regimen, including bisphosphonates * More than 7 days since prior antiplatelet medications or clopidogrel * More than 3 days since prior acetylsalicylic acid (aspirin), ibuprofen, or other NSAIDs * No prior treatment of the portion of a lesion within 0.5 cm of the spinal cord or brain, within 0.5 cm of a large abdominal vessel such as the aorta or inferior vena cava, or within 1 cm of bowel or bladder * No prior radiofrequency ablation for pain palliation of the same lesion * No concurrent regular or low molecular weight heparin or other anticoagulants
References
Publications (0)
Data not yet available
No reference posted for this study.