Status:
RECRUITING
Focused Ultrasound and RadioTHERapy for Noninvasive Palliative Pain Treatment in Patients With Bone Metastases
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Turku University Hospital
Universitätsklinikum Köln
Conditions:
Bone Metastases
Bone Neoplasm
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 optio...
Detailed Description
Rationale: Cancer induced bone pain (CIBP) as a result of bone metastases strongly interferes with quality of life and daily functioning of patients with advanced cancer. The current standard of care ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04307914
Start Date
March 10 2020
End Date
June 1 2026
Last Update
February 7 2024
Active Locations (6)
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1
TUCH Turku
Turku, Finland
2
University Hospital Cologne
Cologne, Germany
3
IOR
Bologna, Italy
4
CSSP
Roma, Italy