MRI Guided High Intensity Focused Ultrasound (HIFU) and ThermoDox for Palliation of Painful Bone Metastases
NCT ID: NCT01640847
Last Updated: 2017-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE2
INTERVENTIONAL
2012-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Arm NRT: HIFU plus ThermoDox
Subjects have no yet received any radiation to the index lesion.
High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Interventions
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High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Philips Healthcare
INDUSTRY
Imunon
INDUSTRY
Responsible Party
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Principal Investigators
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Nicholas Borys, M.D.
Role: STUDY_DIRECTOR
Imunon
Other Identifiers
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106-10-201
Identifier Type: -
Identifier Source: org_study_id
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