Study Comparing the Safety and Effectiveness of Magnetic Resonance Guided Focused Ultrasound (MRgFUS) and External Beam Radiation (EBRT) for Treatment of Metastatic Bone Tumors and Multiple Myeloma

NCT01091883 | Completed

• 1 other identifier: BM016
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to collect comparative data on safety and efficacy of MR Guided Focused Ultrasound and External Beam Radiation for treatment of metastatic bone tumors or multiple myeloma.

Conditions

Bone Cancer; Bone Metastases; Pain

Keywords

Bone cancer; Bone Metastases; pain palliation; metastasis; breast cancer; lung cancer; prostate cancer; cancer related pain; tumors

Outcome Measures

Primary Outcomes (2)

• Safety of treatment

  Incidence and severity of adverse events associated with the ExAblate MRgFUS bone system used in the palliation of pain due to metastatic bone tumors or multiple myeloma to that of EBRT

  6 months

• NRS score

  Effect of treatment with MRgFUS ExAblate Bone System (BS) of painful bone tumors or multiple myeloma

  6 months

Secondary Outcomes (2)

• Pain Medication dose and quantity

  6 months

• Quality of Life score

  6 months

Study Arms (2)

Exablate treatment

EXPERIMENTAL

Exablate 2000

Device: Exablate treatment

Radiation

ACTIVE COMPARATOR

External Beam Radiation

Radiation: Radiation

Interventions

Exablate treatment DEVICE

MR Guided Focused Ultrasound

Exablate treatment

Radiation RADIATION

External Beam Radiation

Radiation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women age 18 years and older.
• Able and willing to give consent and to attend all study visits
• Patients with bone metastasis or primary bone lesion identifiable by imaging techniques.
• Worst NRS Pain Score of ≥ 4 from the tumor to be treated.
• Targeted tumor(s) are accessible to both ExAblate and EBRT (ExAblate accessible lesions 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), please see ExAblate "Information for Prescribers".
• Targeted tumor(s) area is smaller than 100cm2.
• Tumor(s) clearly visible by non-contrast MRI.
• No radiation therapy to the treated lesion during one month prior to enrollment.
• Radiation therapy is not contraindicated
• Bisphosphonate, chemo or hormone therapy intake should remain stable throughout follow up duration.

You may not qualify if:

• Patients who either
• Need pre-treatment surgical stabilization of the affected bony structure OR
• prior surgical stabilization of tumor site
• Targeted tumor is in a vertebra body or in the posterior aspects of the cervical part of the vertebral column.
• Targeted tumor is in the skull.
• Patients on anti-coagulation therapy or with an underlying uncontrolled bleeding disorder.
• Patients with life expectancy \< 6-Months.
• Patients with unstable cardiac status including:
• Unstable angina pectoris on medication.
• Patients with documented myocardial infarction within last 40 days to protocol entry.
• Congestive heart failure NYHA Class IV
• Severe hypertension (diastolic BP \> 100 on medication).
• Patients with standard contraindications for MR imaging such as non-MRI compatible implanted ferromagnetic objects/devices.
• Known intolerance or allergies to MRI contrast agent (e.g. Gadolinium or Magnevist)
• KPS score of below 60

Sponsors & Collaborators

• InSightec: lead

Study Sites (1)

Taipei Medical University Hospital

Taipei City, Taipei, 11031, Taiwan

Location

Related Publications (1)

• Bertrand AS, Iannessi A, Natale R, Beaumont H, Patriti S, Xiong-Ying J, Baudin G, Thyss A. Focused ultrasound for the treatment of bone metastases: effectiveness and feasibility. J Ther Ultrasound. 2018 Nov 30;6:8. doi: 10.1186/s40349-018-0117-3. eCollection 2018.

  PMID: 30519467 DERIVED

Related Links

• Sponsor's Website

MeSH Terms

Conditions

Bone Neoplasms; Pain; Neoplasm Metastasis; Breast Neoplasms; Lung Neoplasms; Prostatic Neoplasms; Cancer Pain; Neoplasms

Interventions

Radiation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Bone Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplastic Processes; Pathologic Processes; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2010
• First Posted: March 24, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 13, 2019

Record last verified: 2019-03

Locations

TW (1)