We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01640847
First Posted: July 16, 2012
Last Update Posted: February 7, 2017
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.
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Celsion
  Purpose
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 Adenocarcinoma Drug: High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Celsion:

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

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

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

  Eligibility

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01640847


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

Responsible Party: Celsion
ClinicalTrials.gov Identifier: NCT01640847     History of Changes
Other Study ID Numbers: 106-10-201
First Submitted: July 12, 2012
First Posted: July 16, 2012
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:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Adenocarcinoma
Neoplasm Metastasis
Neoplasms, Second Primary
Small Cell Lung Carcinoma
Pain
Breast Neoplasms
Bone Neoplasms
Bone Marrow Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplastic Processes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Breast Diseases
Skin Diseases
Bone Diseases
Musculoskeletal Diseases