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

NCT ID: NCT05250687

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-30
• Study Completion Date: 2024-12-31

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.

Conditions

Bone Metastases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MR guided high intensity focused ultrasound (MR-HIFU)

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.

Group Type: EXPERIMENTAL

MR- High intensity focused ultrasound

Intervention Type: 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.

External beam radiation therapy (EBRT)

Patients will undergo radiotherapy for painful bone metastases.

Group Type: ACTIVE_COMPARATOR

External beam radiotherapy

Intervention Type: 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.

Interventions

MR- High intensity focused ultrasound

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: PROCEDURE

External beam radiotherapy

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.

Intervention Type: RADIATION

Other Intervention Names

MR-HIFU; EBRT

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 18 years

2. Painful metastatic bone lesions, with NRS > 4 documented at screening visit

3. Pain from target lesion is distinguishable from other lesions*

4. Target lesion lovation is accessible for MR-HIFU and EBRT**

5. Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening, with a maximum diameter of 8 cm.

6. Reasonable performance score (KPS > 50% or ECOG <3)

7. Life expectancy > 3 months as determined by the study PI or referring oncologist

8. 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

1. Previous surgery, radiation, HIFU, or other local therapy on the target location

2. Neurological symptoms due to nerve involvement of target lesion

3. Need for surgery of targeted location due to (impending) pathological fracture

4. Unavoidable critical structures or dense tissues in target area*

5. Curative intention of treatment plan

6. Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.

7. 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

8. Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients

9. Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist

10. 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

11. Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment

12. 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pejman Ghanouni, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

Other Identifiers

IRB-62458

Identifier Type: -

Identifier Source: org_study_id