Working… Menu
Trial record 12 of 38 for:    focused ultrasound | met

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01640847
Recruitment Status : Withdrawn
First Posted : July 16, 2012
Last Update Posted : February 7, 2017
Philips Healthcare
Information provided by (Responsible Party):

Brief Summary:
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 or disease Intervention/treatment Phase
Painful Bone Metastases Breast Carcinoma Non-small Cell Lung Cancer Small Cell Lung Cancer Adenocarcinoma Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Rate of complete pain response [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Adverse Events [ Time Frame: 3 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01640847

Sponsors and Collaborators
Philips Healthcare
Layout table for investigator information
Study Director: Nicholas Borys, M.D. Celsion

Layout table for additonal information
Responsible Party: Celsion Identifier: NCT01640847     History of Changes
Other Study ID Numbers: 106-10-201
First Posted: July 16, 2012    Key Record Dates
Last Update Posted: February 7, 2017
Last Verified: February 2017
Keywords provided by Celsion:
Painful bone metastases
Bone Cancer
Bone Cancer Pain
Patients with
Additional relevant MeSH terms:
Layout table for MeSH terms
Neoplasm Metastasis
Lung Neoplasms
Small Cell Lung Carcinoma
Breast Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes
Breast Diseases
Skin Diseases
Neurologic Manifestations
Signs and Symptoms
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases