Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases

Summary

The FURTHER study aims to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) compared to EBRT alone, the standard-of-care, as a palliative treatment option to relieve CIBP. The FURTHER study consists of a multicenter, three-armed randomized controlled trial (FURTHER RCT) and a patient registry arm (FURTHER Registry), which will be performed in six hospitals in four European countries.

Conditions

• Bone Metastases
• Bone Neoplasm
• Bone Lesion
• Bone Cancer
• Pain
• Cancer Induced Bone Pain
• Quality of Life
• Tumor
• Neoplasm Metastasis

Interventions

RADIATION

External beam radiotherapy

The current standard of care for patients with uncomplicated painful bone metastases is palliative locoregional external beam radiotherapy, often in combination with systemic therapy and analgesics.

PROCEDURE

MR-HIFU

MR-HIFU is a non-invasive treatment modality that delivers acoustic energy to heat tissue to ablative temperatures of more than 60°C. The combination of focused ultrasound with magnetic resonance imaging (MRI) enables physicians to perform localized tumor tissue ablation, with real-time temperature monitoring using magnetic resonance (MR) thermometry.

Sponsors & Collaborators

• Turku University Hospital

  collaborator OTHER_GOV

• Universitätsklinikum Köln

  collaborator OTHER

• University of Roma La Sapienza

  collaborator OTHER

• Istituto Ortopedico Rizzoli

  collaborator OTHER

• University of Bologna

  collaborator OTHER

• Isala

  collaborator OTHER

• UMC Utrecht

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-03-10

Primary Completion

2025-09-01

Completion

2026-12-01

Countries

• Finland
• Germany
• Italy
• Netherlands

Study Locations