This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.
The primary purpose of this study is to see if MR guided high intensity focused ultrasound (MR-HIFU) treats bone pain faster than the standard radiation therapy (External beam radiation therapy: EBRT) and to evaluate the patient's pain experience 14 days after completion of the treatment. The secondary purpose is to evaluate the outcomes of the pain, side effects, and quality of life and survival in the first 6 months after treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
The intervention treatment is MR-HIFU, which will be given as a standalone treatment. MRHIFU treatment will be delivered using the ExAblate 2100 System (INSIGHTEC, Tirat Carmel, Israel), which is an FDA-approved device for pain palliation of bone metastasesThe ExAblate focused ultrasound device operates in conjunction with an MRI machine. Gadavist is being administered intraveneously as contrast medium for MRI.
Standard of care for pain palliation of bone metastases consists of single fraction external beam radiotherapy of 8-16 Gray (Gy) or a multi-fraction regime of 20 Gy in 5 fractions, 24 Gy in 6 fractions or 30 Gy in 10 fractions. The radiation schedule is at the discretion of the treating radiation oncologist.
Stanford University
Palo Alto, California, United States
Number of participants that achieve a complete response (CR) or partial response (PR)
Complete response (CR): Complete response is defined as a pain score of zero at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalents). Partial Response (PR): Partial response is to be defined as any of the following: Pain reduction of 2 or more points at the treated site on a 0-10 scale without analgesic increase; or analgesic dose reduction of 25% or more in daily morphine equivalent from baseline without an increase in pain.
Time frame: 14 days after treatment
Patient-reported pain scores - Pain Diary
Patient reported pain scores will be based on a Numeric Rating Scale (NRS) (from 0 to 10) 0 = no pain and 10= worst pain. Assessed using the patient pain diary from treatment day to 1 month after completion treatment.
Time frame: 1 month
Patient-reported pain scores - BPI (Brief Pain Inventory)
The BPI measures pain interference on seven 0-10 integer subscales, as well as the mean of the seven subscales.
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
Physician-reported adverse events
Assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0; we will report the number of pathologic fractures at the site of treatment
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
Patient-reported quality of life - EORTC QLQ-BM22
During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
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Patient-reported quality of life - EORTC QLQ-C15-PAL
During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
Patient-reported quality of life - EQ-5D-5L
During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment.
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
Patient-reported quality of life - PGIC
During follow up, patient will received quality of life questionnaire on baseline, at 2 and 4 weeks, and at 3 and 6 months after completion of treatment. Patient Global Impression of Change scale has a single question with a 7 point likert scale about overall improvement after treatment assessing change in pain, from "Much Better" to "Much Worse"
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months
Local tumor control
Assessed using CT and/or MRI imaging at three and/or six months after completion of treatment
Time frame: 3 and 6 months after completion of treatment
Anxiety and depression scores
Assessed by the Hospital Anxiety and Depression Scale (HADS). This measures anxiety and depression separately on seven four-point (0-3) subscales, giving total scores from 0-21 for both constructs.
Time frame: on baseline, at 2 and 4 weeks, and at 3 and 6 months