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

Launched by UMC UTRECHT · Mar 12, 2020

Keywords

ClinConnect Summary

The FURTHER study is a clinical trial that is looking at new ways to relieve pain for patients who have painful bone lesions caused by cancer, specifically those with bone metastases. This trial is comparing a treatment using focused ultrasound (called MR-HIFU) either alone or combined with traditional radiation therapy (EBRT) against EBRT alone, which is the standard treatment. The goal is to see which method works best for easing cancer-induced bone pain and improving the quality of life.

To participate in this study, patients must be at least 18 years old and able to provide informed consent. They should have painful bone lesions that are clearly seen on recent imaging tests like CT or MRI. Additionally, their overall health should be stable enough to expect some benefit from the treatments. Participants can expect to receive one of the treatment options and will be monitored throughout the trial. It's important to note that certain individuals, such as those who cannot fit in the MRI machine, those needing immediate surgery for fractures, or those with specific medical conditions, may not be eligible to join. The study is currently recruiting participants across six hospitals in four European countries.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient capable of giving informed consent
• • Age ≥ 18 years
• • Painful metastatic bone lesion (NRS \> 2)
• • Patient-localised pain with a distinct pathological substrate on recent CT/MRI
• • Target lesion location is sufficiently accessible for MR-HIFU to expect clinical response, as judged by the (intervention) radiologist
• • Participant has a reasonable performance score (KPS ≥ 50% or Zubrod/ECOG/WHO \< 3)
• • Life expectancy ≥ 3 months
• Exclusion Criteria:
• • Participant is not able to fit in the MR gantry
• • Need for surgery of targeted location due to (impending) pathological fracture
• • Unavoidable critical structures or dense tissues in target area
• • Contra-indications for MRI or sedation/anesthesia
• • Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
• • Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
• • All patients meeting the FURTHER in- and exclusion criteria as described above will be included in this study, either in the FURTHER RCT or FUTHER Registry. The following inclusion criteria are used to decide upon the arm patients will participate in. If patients meet all of the following RCT inclusion criteria, they will be asked to participate in the FURTHER RCT. Alternatively, patients who do not meet one or more of these criteria will be asked to participate in the FURTHER Registry.
• • Painful bone lesion (NRS ≥ 4)
• • Indication for EBRT treatment of a bone lesion
• • Exclusively palliative intention of EBRT treatment plan
• • No previous surgery on the target location
• • No neurological symptoms due to nerve involvement of target lesion
• • No (impending) pathological fracture)
• • EBRT replacable by MR-HIFU based on medical history or phyiscal findings judged by multidisciplinary team
• • Target lesion location is completely accessible for MR-HIFU