Combining radiotherapy and focused ultrasound for pain palliation of cancer induced bone pain; a stage I/IIa study according to the IDEAL framework

Abstract

Background: Cancer induced bone pain (CIBP) strongly interferes with patient's quality of life. Currently, the standard of care includes external beam radiotherapy (EBRT), resulting in pain relief in approximately 60% of patients. Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) is a promising treatment modality for CIBP. Methods: A single arm, R-IDEAL stage I/IIa study was conducted. Patients presenting at the department of radiation oncology with symptomatic bone metastases in the appendicular skeleton, as well as in the sacrum and sternum were eligible for inclusion. All participants underwent EBRT, followed by MR-HIFU within 4 days. Safety and feasibility were assessed, and pain scores were monitored for 4 weeks after completing the combined treatment. Results: Six patients were enrolled. Median age was 67 years, median lesion diameter was 56,5 mm. In all patients it was logistically possible to plan and perform the MR-HIFU treatment within 4 days after EBRT. All patients tolerated the combined procedure well. Pain response was reported by 5 out of 6 patients at 7 days after completion of the combined treatment, and stabilized on 60% at 4 weeks follow up. No treatment related serious adverse events occurred. Conclusion: This is the first study to combine EBRT with MR-HIFU. Our results show that combined EBRT and MR-HIFU in first-line treatment of CIBP is safe and feasible, and is well tolerated by patients. Superiority over standard EBRT, in terms of (time to) pain relief and quality of life need to be evaluated in comparative (randomized) study.

Focused Ultrasound and RadioTHERapy for Non-Invasive Palliative Pain Treatment in Patients with Bone Metastasis: A Study Protocol for the Three Armed Randomized Controlled FURTHER-trial

“…In the (or "a" or "our") previous research, it was shown that the combined treatment of EBRT and MR-HIFU is feasible and safe. 25 Clinical outcomes were promising and need to be further assessed in this comparative trial.…”

“…[14][15][16][17][18][19][20][21] Moreover, combining MR-HIFU with EBRT may have a complementary or even synergistic effect on pain response. [22][23][24][25] In an earlier study the feasibility of combined treatment was proven. 25 Still, high quality evidence and context is needed to determine the role of MR-HIFU in the rst-line treatment options of patients with CIBP.…”

“…[22][23][24][25] In an earlier study the feasibility of combined treatment was proven. 25 Still, high quality evidence and context is needed to determine the role of MR-HIFU in the rst-line treatment options of patients with CIBP. The FURTHER-consortium sets out to provide this evidence and to evaluate the effectiveness and cost-effectiveness of MR-HIFU (alone or in combination with EBRT) as a palliative treatment option for patients with CIBP caused by bone metastases.…”

Clinical implementation and initial experience with a 1.5 Tesla MR-linac for MR-guided radiotherapy for gynecologic cancer: An R-IDEAL stage 1/2a first in humans/feasibility study of new technology implementation

“…This assessment included both an "idea" stage (R-IDEAL Stage 1; that is, first-in-human implementation) and a "development" stage (R-IDEAL Stage 2a; that is, reporting technical feasibility "when additional modifications are made to further optimize workflow and technology for innovative treatment delivery." 10 The R-IDEAL conceptual schema allows technology development to be substantiated iteratively as parts of a coherent programmatic project 8,[11][12][13][14][15] and is analogous to the parent IDEAL method for surgery. 16 The aim of the current study was to demonstrate the first-in-human implementation of adaptive MR-guided radiotherapy (MRgRT) for gynecologic external-beam application (R-IDEAL Stage 1).…”

Design, fabrication and actuation of magneto-acoustic microrobots: een deel magnetisch, een ander deel akoestisch, allebei fantastisch

“…However, the integration of these immersible arrays into clinical systems is limited for a couple of reasons. First, these arrays often require a large number of sophisticated transducers that are high-end commercial products such as systems developed by Verasonics Inc. [43], Imasonic SAS [297] and Phillips B.V. [299]. Further, the overall cost in such a system integration is also burdened by the expensive peripheral equipment employed for functions such as pressure amplification and data acquisition.…”