Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bo… (NCT04310410) | Clinical Trial Compass
CompletedPhase 1/2
Feasibility of Combined Focused Ultrasound and Radiotherapy Treatment in Patients With Painful Bone Metastasis
Netherlands10 participantsStarted 2019-04-11
Plain-language 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 the combined treatment logistics. Six to ten patients will be included according to in- and exclusion criteria.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 predominan…
What they're measuring
1
Feasibility of combined treatment with EBRT and MR-HIFU - Patient tolerance: questionnaire
Timeframe: 4 weeks
2
Feasibility of combined treatment with EBRT and MR-HIFU - hospital logistics