MR Guided Focused Ultrasound vs Radiotherapy for Palliative Pain Tx in Bone Metastases

NCT05250687 | Withdrawn FDA Device

• 1 other identifier: IRB-62458
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Metastases

Outcome Measures

Primary Outcomes (1)

• 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.

  14 days after treatment

Secondary Outcomes (9)

• Patient-reported pain scores - Pain Diary

  1 month

• Patient-reported pain scores - BPI (Brief Pain Inventory)

  on baseline, at 2 and 4 weeks, and at 3 and 6 months

• Physician-reported adverse events

  on baseline, at 2 and 4 weeks, and at 3 and 6 months

• Patient-reported quality of life - EORTC QLQ-BM22

  on baseline, at 2 and 4 weeks, and at 3 and 6 months

• Patient-reported quality of life - EORTC QLQ-C15-PAL

  on baseline, at 2 and 4 weeks, and at 3 and 6 months

Study Arms (2)

MR guided high intensity focused ultrasound (MR-HIFU)

EXPERIMENTAL

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.

Procedure: MR- High intensity focused ultrasound

External beam radiation therapy (EBRT)

ACTIVE COMPARATOR

Patients will undergo radiotherapy for painful bone metastases.

Radiation: External beam radiotherapy

Interventions

MR- High intensity focused ultrasound PROCEDURE

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.

Also known as: MR-HIFU

MR guided high intensity focused ultrasound (MR-HIFU)

External beam radiotherapy RADIATION

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.

Also known as: EBRT

External beam radiation therapy (EBRT)

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94306, United States

Location

Study Officials

• Pejman Ghanouni, MD, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 22, 2022
• Study Start: June 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)