Using focused ultrasound and radiotherapy to relieve pain from bone metastases
Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases
This study is testing whether a new ultrasound treatment alone or with radiation can help relieve pain faster for people with painful bone cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 216 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 6 sites (Turku and 5 other locations) |
| Trial ID | NCT04307914 on ClinicalTrials.gov |
What this trial studies
The FURTHER study evaluates the effectiveness and cost-effectiveness of magnetic resonance image-guided high-intensity focused ultrasound (MR-HIFU) alone or in combination with external beam radiotherapy (EBRT) for palliative treatment of cancer-induced bone pain (CIBP). This multicenter, three-armed randomized controlled trial will include 216 patients with painful bone metastases, who will be randomized to receive either EBRT only, MR-HIFU only, or EBRT followed by MR-HIFU. The study aims to provide quicker pain relief compared to the standard EBRT, which can take weeks to show effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with painful metastatic bone lesions and a reasonable performance status.
Not a fit: Patients who cannot undergo MRI or have critical structures in the target area may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pain relief for patients suffering from cancer-induced bone pain.
How similar studies have performed: Other studies have explored similar approaches, but this specific combination of MR-HIFU and EBRT is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Turku and 5 other locations
- TUCH Turku — Turku, Finland (Recruiting)
- University Hospital Cologne — Cologne, Germany (Recruiting)
- Ior — Bologna, Italy (Recruiting)
- Cssp — Roma, Italy (Recruiting)
- University Medical Center Utrecht — Utrecht, Netherlands (Recruiting)
- Isala Klinieken Zwolle — Zwolle, Netherlands (Recruiting)
Study contacts
- Study coordinator: Renée Hovenier, MSc
- Email: r.hovenier-2@umcutrecht.nl
- Phone: +31 6 5017 78 43
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.