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Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients with Bone Metastasis

Project description

Ultrasound technology for the palliative treatment of metastatic bone pain

Bone metastases with devastating pain are common in advanced cancer, and metastatic bone pain (MBP) is hard to manage. Radiation therapy (RT) is the standard palliative treatment for MBP, but it often results in inadequate pain relief. Magnetic resonance high-intensity focussed ultrasound (MR-HIFU) uses the aid of magnetic resonance imaging to focus an ultrasound beam to heat and destroy the tissue in the lesion. Preliminary studies suggest that MR-HIFU induces rapid pain relief. The EU-funded FURTHER project aims to demonstrate the effectiveness of MR-HIFU as an alternative or additional treatment option to relieve MBP. The project will conduct a randomised controlled trial comparing pain response in patients treated with RT only, MR-HIFU only and RT combined with MR-HIFU. Moreover, it will investigate the wider adoption of MR-HIFU and ways to increase access to it.

Objective

"Bone metastases are a common manifestation of advanced cancer, with pain as a devastating consequence. Due to rising cancer incidence rates and improving survival, the number of cancer patients living long enough to develop bone metastases is increasing rapidly. Metastatic bone pain is difficult to manage and has a detrimental impact on quality of life of patients, their partners and care-givers.

Radiation therapy (RT), the standard treatment for palliation of metastatic bone pain, is easy to administer and well tolerated. However, RT is only effective in 60-70% of patients and usually takes four weeks before inducing pain response. Inadequate pain relief is therefore common and alternative treatment options are urgently needed.

Pain palliation may be substantially improved by including MR-HIFU as alternative or in addition to RT. Preliminary studies suggest that MR-HIFU induces rapid pain relief (within days), and may palliate pain in patients in whom RT is not effective. Currently, strong evidence and context is lacking for wide-spread implementation of MR-HIFU into routine care.

The FURTHER project aims to demonstrate (cost)effectiveness of MR-HIFU as an alternative or additional treatment option to relief metastatic bone pain. For this purpose, a three arm international randomized controlled trial (RCT) including 216 patients will be conducted comparing early and late pain response in patients treated with RT only, MR-HIFU only, and RT with MR-HIFU. A prediction model will be developed to identify patients who are likely to benefit from MR-HIFU in order to allow (cost-) effective use of the treatment. In addition, a registry will be set up in which we will run the pain education study Educate-FURTHER, henceforth ""the Pain Education study"", to evaluate the effectiveness of adding pain education to the pain management strategy. Finally, FURTHER will map and analyse socio-economic barriers for integration of MR-HIFU in routine care in the wider European context and make recommendations on how to provide equal access to this promising new treatment."

Call for proposal

H2020-SC1-BHC-2018-2020

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Sub call

H2020-SC1-2018-Single-Stage-RTD

Coordinator

UNIVERSITAIR MEDISCH CENTRUM UTRECHT
Net EU contribution
€ 1 093 122,50
Address
HEIDELBERGLAAN 100
3584 CX Utrecht
Netherlands

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Region
West-Nederland Utrecht Utrecht
Activity type
Higher or Secondary Education Establishments
Links
Total cost
€ 1 093 122,50

Participants (10)