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A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of 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.
ClinicalTrials.gov Identifier: NCT03086824
Recruitment Status : Unknown
Verified March 2017 by Jo-Ting Tsai, Taipei Medical University Shuang Ho Hospital.
Recruitment status was:  Active, not recruiting
First Posted : March 22, 2017
Last Update Posted : March 22, 2017
Sponsor:
Information provided by (Responsible Party):
Jo-Ting Tsai, Taipei Medical University Shuang Ho Hospital

Brief Summary:
The purpose of this study is to investigate the safety and effectiveness of subjects receiving MR-guided Focused Ultrasound (MRgFUS) treatment for painful bone metastases. This study will evaluate treatment response and clinically significant adverse events. Other relevant data may be documented as well.

Condition or disease Intervention/treatment Phase
Magnetic Resonance Guided Interventional Procedures Device: magnetic resonance-guided focused ultrasound Phase 4

Detailed Description:
This proposed study will be performed in full compliance with all applicable privacy rules and regulations, and their implementations at participating site(s). All subjects planned to undergo the MRgFUS procedure at Taipei Medical University Hospital will be offered informed consent so they can be included in this Study.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Safety Evaluation of MR-guided Focused Ultrasound Treatment for Palliative Pain Control of Bone Metastases
Actual Study Start Date : December 12, 2014
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: MRgFUS
Patients with painful bone metastases receiving magnetic resonance-guided focused ultrasound treatment.
Device: magnetic resonance-guided focused ultrasound



Primary Outcome Measures :
  1. Treated-related Adverse Events [ Time Frame: 12-months ]

Secondary Outcome Measures :
  1. Change from baseline Quality of Life Questionnaire [ Time Frame: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months ]
  2. Change from baseline Pain Score [ Time Frame: 1day, 3days, 1-week, 2-weeks, 1-month, 2-months, 3-months, 6-months, 9-months, 12-months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Men and women age 20 and older.
  2. Patients who are able and willing to give consent and able to attend all study visits.
  3. Patients who are suffering from symptoms of bone metastases: Patients who have received radiation without adequate relief from metastatic bone pain as determined by the patient and treating physician, those for whom their treating physician would not prescribe radiation or additional radiation treatments, and those patients who refuse additional radiation therapy.
  4. Patient with NRS (0-10 scale) pain score ≥ 4 irrespective of medication.
  5. Targeted bone/tumor interface are ExAblate device accessible and are located in ribs, extremities (excluding joints), pelvis, shoulders and in the posterior aspects of the following spinal vertebra: Lumbar vertebra (L3-L5), Sacral vertebra (S1-S5).
  6. Patient whose targeted lesion is on bone and the interface between the bone and lesion is deeper than 10-mm from the skin.
  7. Targeted (treated) tumor clearly visible by non-contrast MRI, and ExAblate MRgFUS device accessible.
  8. Patients on ongoing chemotherapy regimen at the time of eligibility: 1) with same chemotherapy regimen (as documented from patient medical dossier, 2) worst pain NRS still ≥ 4, and 3) do NOT plan to initiate a new chemotherapy for pain palliation should be eligible for the study. Note: Planned multiple courses of chemotherapy are not considered New Chemotherapy.
  9. No radiation therapy to targeted (most painful) lesion in the past two weeks.
  10. Bisphosphonate intake should remain stable throughout the study duration. -

Exclusion Criteria:

  1. Patients who either Need surgical stabilization of the affected bony structure or Targeted tumor is at an impending fracture site or Surgical stabilization of tumor site with metallic hardware.
  2. KPS (Karnofsky performance scale) Score < 60.
  3. Unable to communicate sensations during the ExAblate treatment.
  4. Target (treated) tumor is less then 10-mm from nerve bundles, bowels or bladder.
  5. Patients with acute medical condition (e.g., pneumonia, sepsis) that is expected to hinder them from completing this study.
  6. Severe cerebrovascular disease (multiple CVA or CVA within 6 months).
  7. Patients with unstable cardiac status (e.g. unstable angina pectoris, myocardial infarction within 6 months, congestive heart failure NYHA Class IV, on arrhythmic drugs).
  8. Severe hypertension (diastolic BP > 100 mmHg on medication).
  9. Patients on dialysis.
  10. Patients with standard contraindications for MRI or 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 ClinicalTrials.gov identifier (NCT number): NCT03086824


Locations
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Taiwan
Department of Radiation Oncology, Taipei Medical University Hospital
Taipei, Taiwan, 110
Sponsors and Collaborators
Taipei Medical University Shuang Ho Hospital

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Responsible Party: Jo-Ting Tsai, Doctor of Philosophy(Ph.D.)/Director, Department of Radiation Oncology, Taipei Medical University - Shuang Ho Hospital, New Taipei, Taiwan, Taipei Medical University Shuang Ho Hospital
ClinicalTrials.gov Identifier: NCT03086824     History of Changes
Other Study ID Numbers: TMU-SHH-2014-001
First Posted: March 22, 2017    Key Record Dates
Last Update Posted: March 22, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Jo-Ting Tsai, Taipei Medical University Shuang Ho Hospital:
Bone Metastasis

Additional relevant MeSH terms:
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Neoplasm Metastasis
Neoplastic Processes
Neoplasms
Pathologic Processes