Clinical trial · Interventional
MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases
NCT01640847CI-TRIAL-00025809withdrawnPhase 2ClinicalTrials.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)
This study will evaluate treatment with High Intensity Focused Ultrasound (HIFU)in combination with ThermoDox (liposomal doxorubicin) is safe and effective in reducing pain for patients with painful bone metastases.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma | Adenocarcinoma | ONTOLOGY_EXACT | 0.90 |
| Breast Carcinoma | Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| Painful Bone Metastases | — | UNRESOLVED | — |
| Small Cell Lung Cancer | Lung Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm RT: HIFU plus ThermoDox
- description
- Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
- interventionNames
- Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
- type
- EXPERIMENTAL
- label
- Arm NRT: HIFU plus ThermoDox
- description
- Subjects have no yet received any radiation to the index lesion.
- interventionNames
- Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Primary outcomes (1)
- measure
- Rate of complete pain response
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histological confirmation of breast carcinoma, non-small cell lung cancer, small cell lung cancer, or adenocarcinoma of the prostate * Bone metastases index lesion in the ribs, clavicle, scapula, upper extremities, pelvis, or posterior aspects of the lumbar vertebra L3-L5 or sacral S1-S5. * Patients will have failed at least one prior attempt or will not be eligible for external beam radiation therapy (EBRT) Exclusion Criteria: * Greater than 450 mg/m2 of prior free doxorubicin and/or non-heat activated liposomal doxorubicin * LVEF \< 50% * Significant Cardiac History * Brain Metastases * Contraindication for MR imaging (as incompatible implanted metallic device, weight \>250 lbs etc) or known intolerance or allergy to MRI contrast agents.
References
Publications (0)
Data not yet available
No reference posted for this study.