Status:
COMPLETED
Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
Isala
Conditions:
Bone Metastases
Bone Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The PRE-FURTHER study aims to evaluate the feasibility of the combined treatment with radiotherapy and focussed ultrasound for pain palliation in patients with painful bone metastases, and to optimize...
Detailed Description
Rationale: Metastatic bone pain strongly interferes with quality of life and daily functioning of patients with advanced cancer. Pain palliation may be improved by including magnetic resonance image g...
Eligibility Criteria
Inclusion
- Men and women with age ≥ 18 years
- Patient capable of giving informed consent and able to attend study visits
- Uncomplicated painful bone metastases
- Weight \<140kg and able to fit in the MRI gantry
- Radiologic evidence of bone metastases from any solid tumor
- Pain is localized to the targeted area, or is likely to be referred pain arising from the targeted area
- Pain related to the target lesion is refractory to less invasive treatments for pain relief
- Multiple metastatic lesions, with one predominantly painful lesion (\>=2 points higher pain score than other lesions). The lesion should be clearly distinguishable from other painful lesions.
- Device accessible tumors: extremities (excluding joints), pelvis, shoulders, posterior vertebral spine below L5, in selected cases ribs and sternum
- Target lesion maximum dimension ≤ 8cm
- Intended target volume visible by non-contrast MR imaging
- Distance between target and skin ≥ 1cm
- Numeric Rating Scale (NRS) score \>= 4 or equivalent
- Life expectancy \>3 months
Exclusion
- Planned treatment lesion is a primary bone tumor or due to lymphoma, multiple myeloma, or leukemia.
- Communication barrier present
- Patient enrolled in another clinical study related to bone metastases treatment or pain relief treatment
- Unable to tolerate required stationary position during treatment despite adequate pain medication
- Need for surgery
- Pregnant woman
- Pain related to target lesion is predominantly due to fracture or impending fracture
- Pain related to target lesion is due to involvement of a neighboring major nerve by the metastatic tumor (cord or nerve compression)
- Target \< 3cm from bladder / bowel / nerve along the beam path and \< 1cm in the plane orthogonal to the beam
- Target in contact with hollow viscera
- Target located in skull, joints, ribs (when HIFU beam overlapping with lung), spine (excluding sacrum which is allowed) or in most cases sternum
- Internal or external fixation device along the proposed HIFU beam path or at the target
- MRI contraindicated (e.g. paramagnetic implants, pacemaker, claustrophobia)
- MRI contrast agent contraindicated (e.g. previous anaphylaxis or Glomerular Filtration Rate \< 20 ml/min/1.73m2)
- Sedation contraindicated
- Previous surgery or minimally invasive treatment at targeted site within the last three months
- Clinically relevant medical history or abnormal physical findings that could interfere with the safety of the participant as judged by the treating physician or investigator
- Karnofsky performance score (KPS) \< 60%
- Oligometastatic disease planned for curative treatment
- Indication for stereotactic radiotherapy (e.g. patients with radioresistant histology such as renal cell, melanoma, sarcoma metastases)
- History of photodermatoses (of the skin overlying the target area)
- Need for remineralisation
Key Trial Info
Start Date :
April 11 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2020
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04310410
Start Date
April 11 2019
End Date
June 1 2020
Last Update
February 7 2024
Active Locations (2)
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1
Isala Klinieken Zwolle
Zwolle, Overijsel, Netherlands, 8025 AB
2
University Medical Center Utrecht
Utrecht, Netherlands, 3508GA