MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone Metastases

Summary

Bone metastasis give rise to major complications that lead to significant morbidity and impairment of life quality. The most common primary for bone metastasis is prostate, lung and breast carcinoma. These three have the highest cancer incidence in the USA with up to 85% prevalence of bone metastases at the time of death. Pain from these osseous lesions can be related to mechanical or chemical factors. Pressure effects on the periosteum or adjacent neural structures can cause local or radiating pain. Hemorrhage from local bone osteolysis by osteoclastic activity causes a local release of bradykinin, prostaglandins, histamine and substance P that can irritate the endosteal nerves as well as local nerves.

The life expectancy of patients with osseous metastatic disease is variable but can be substantially longer for patients with multiple myeloma, breast or prostate cancer. Therefore, finding an effective local therapy that can improve patient quality of life and can be done at a single outpatient sitting would be beneficial.

The current and emerging treatments for osseous metastases may be considered in several categories: radiotherapy, systemic chemotherapy (cytotoxic, hormonal and radionuclides), surgical stabilization and percutaneous tumor ablation. These treatments may be applied in isolation but also frequently in combination.

MRI Guided High Intensity Focused Ultrasound (HIFU) is a completely non-invasive technology for thermal ablation. HIFU is capable of concentrating ultrasonic pressure waves to a specified region without any physical penetration of the body. The converging ultrasonic pressure wave is converted to thermal energy at the specific depth, resulting in local heating at the focus. Temperature elevation is proportional to the proton resonance frequency shift, therefore MR imaging provides accurate technique for target definition and energy deposition control. MRI guided Focused Ultrasound therapy is being performed in treatment of uterine leiomyomas (fibroids). Recently the method has gained both AMAR authorization and FDA approval, and CE approval for that indication.

Clinical trials of HIFU in bone metastases have indicated that the method is safe and gives an effective reduction of patient pain. The short- and long-term effects on tumor volume and morphology do not seem to have been evaluated thus far.

The primary objective of this trial is to evaluate effectiveness of MRI guided HIFU in the treatment of metastatic bone tumors

Conditions

• Bone Metastases
• Bone Neoplasm
• Bone Cancer
• Bone Lesion

Interventions

DEVICE

Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T

Procedure is performed under proper analgesia (general or local anesthesia). The intervention can be performed in areas accessible with ultrasound with no critical structures (nerves, vasculature, bowels) in proximity. Limbs and pelvis are most usually accepted locations. Patient is adjusted on top of the HIFU-transducer connected to MRI. First a MR-scan is performed and the treatment procedure is planned on consol. Then under MRI-guidance a point by point ablation of the target tumor is performed. During the treatment a real-time thermometry is obtained in order to avoid unwanted heating of related structures and to observe sufficient effect on treatment zone. After treatment MR-scan with gadolinium is performed to evaluate the size of ablated area.

DEVICE

Varian Truebeam Radiotherapy System

Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography

Sponsors & Collaborators

• Turku University Hospital

  lead OTHER_GOV

Principal Investigators

• Gaber Komar, PhD, MD · TYKS/VSKK (Turku University Hospital / Proper Finlands Imaging center)

• Mira Huhtala, MD, PhD student · TYKS Oncology (Turku University Hospital)

• Heikki Minn, Professor, MD · TYKS Oncology

• Teija O Sainio, MSc, PhD Student · TYKS/VSKK (Turku University Hospital / Proper Finlands Imaging center)

Study Design

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-15

Primary Completion

2022-01-30

Completion

2022-03-30