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MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases

This study has been withdrawn prior to enrollment.
Philips Healthcare
Information provided by (Responsible Party):
Celsion Identifier:
First received: July 12, 2012
Last updated: March 4, 2016
Last verified: March 2016
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.

Condition Intervention Phase
Painful Bone Metastases
Breast Carcinoma,
Non-small Cell Lung Cancer,
Small Cell Lung Cancer,
Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Phillips MRI-Guided High Intensity Focused Ultrasound (Sonalleve) and Lyso-thermosensitive Liposomal Doxorubicin (ThermoDox) for Palliation of Painful Bone Metastases

Resource links provided by NLM:

Further study details as provided by Celsion:

Primary Outcome Measures:
  • Rate of complete pain response [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse Events [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm RT: HIFU plus ThermoDox
Index lesion has been treated with EBRT and is currently painful, but these subjects have already received their maximum cumulative EBRT dose.
Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Experimental: Arm NRT: HIFU plus ThermoDox
Subjects have no yet received any radiation to the index lesion.
Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT01640847

Sponsors and Collaborators
Philips Healthcare
Study Director: Nicholas Borys, M.D. Celsion
  More Information

Responsible Party: Celsion Identifier: NCT01640847     History of Changes
Other Study ID Numbers: 106-10-201 
Study First Received: July 12, 2012
Last Updated: March 4, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Celsion:
Painful bone metastases
Bone Cancer
Bone Cancer Pain
Patients with

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Neoplasms, Second Primary
Small Cell Lung Carcinoma
Breast Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on October 25, 2016