Back to resultsMR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
Primary Purpose
Bone Metastases
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MR- High intensity focused ultrasound
External beam radiotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Bone Metastases
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Painful metastatic bone lesions, with NRS > 4 documented at screening visit
- Pain from target lesion is distinguishable from other lesions*
- Target lesion lovation is accessible for MR-HIFU and EBRT**
- Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening, with a maximum diameter of 8 cm.
- Reasonable performance score (KPS > 50% or ECOG <3)
- Life expectancy > 3 months as determined by the study PI or referring oncologist
Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
- e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum
Exclusion Criteria:
- Previous surgery, radiation, HIFU, or other local therapy on the target location
- Neurological symptoms due to nerve involvement of target lesion
- Need for surgery of targeted location due to (impending) pathological fracture
- Unavoidable critical structures or dense tissues in target area*
- Curative intention of treatment plan
- Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.
- Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30mL/min/1.73 m^2) or on dialysis
- Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist
- Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report
- Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
- as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device
Sites / Locations
- Stanford University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MR guided high intensity focused ultrasound (MR-HIFU)
External beam radiation therapy (EBRT)
Arm Description
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 metastases.
Patients will undergo radiotherapy for painful bone metastases.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
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
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.
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.
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.
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"
Local tumor control
Assessed using CT and/or MRI imaging at three and/or six 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05250687
Brief Title
MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
Official Title
MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Metastases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
MR guided high intensity focused ultrasound (MR-HIFU)
Arm Type
Experimental
Arm Description
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 metastases.
Arm Title
External beam radiation therapy (EBRT)
Arm Type
Active Comparator
Arm Description
Patients will undergo radiotherapy for painful bone metastases.
Intervention Type
Procedure
Intervention Name(s)
MR- High intensity focused ultrasound
Other Intervention Name(s)
MR-HIFU
Intervention Description
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.
Intervention Type
Radiation
Intervention Name(s)
External beam radiotherapy
Other Intervention Name(s)
EBRT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants that achieve a complete response (CR) or partial response (PR)
Description
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
Secondary Outcome Measure Information:
Title
Patient-reported pain scores - Pain Diary
Description
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
Title
Patient-reported pain scores - BPI (Brief Pain Inventory)
Description
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
Title
Physician-reported adverse events
Description
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
Title
Patient-reported quality of life - EORTC QLQ-BM22
Description
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
Title
Patient-reported quality of life - EORTC QLQ-C15-PAL
Description
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
Title
Patient-reported quality of life - EQ-5D-5L
Description
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
Title
Patient-reported quality of life - PGIC
Description
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
Title
Local tumor control
Description
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
Title
Anxiety and depression scores
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Painful metastatic bone lesions, with NRS > 4 documented at screening visit
Pain from target lesion is distinguishable from other lesions*
Target lesion lovation is accessible for MR-HIFU and EBRT**
Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening, with a maximum diameter of 8 cm.
Reasonable performance score (KPS > 50% or ECOG <3)
Life expectancy > 3 months as determined by the study PI or referring oncologist
Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum
Exclusion Criteria:
Previous surgery, radiation, HIFU, or other local therapy on the target location
Neurological symptoms due to nerve involvement of target lesion
Need for surgery of targeted location due to (impending) pathological fracture
Unavoidable critical structures or dense tissues in target area*
Curative intention of treatment plan
Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.
Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30mL/min/1.73 m^2) or on dialysis
Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist
Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report
Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brittney Williams
Phone
650-497-8588
Email
bw718@stanford.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pejman Ghanouni, MD, PhD
Organizational Affiliation
Stanford University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brittney Williams
Phone
650-497-8588
Email
bw718@stanford.edu
First Name & Middle Initial & Last Name & Degree
Pejman Ghanouni, MD, PhD
First Name & Middle Initial & Last Name & Degree
Lucas Vitzthum, MD, MAS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases
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