MR Guided Focused Ultrasound Versus Radiotherapy for Palliative Pain Treatment in Patients With Bone Metastases
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants that achieve a complete response (CR) or partial response (PR)
研究概览
简要总结
This is a prospective, single-center, randomized study directly comparing outcomes after MR guided high intensity focused ultrasound (MR HIFU) or external beam radiation therapy (EBRT) treatment of painful bone metastases.
详细描述
The primary purpose of this study is to see if MR guided high intensity focused ultrasound (MR-HIFU) treats bone pain faster than the standard radiation therapy (External beam radiation therapy: EBRT) and to evaluate the patient's pain experience 14 days after completion of the treatment. The secondary purpose is to evaluate the outcomes of the pain, side effects, and quality of life and survival in the first 6 months after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •Painful metastatic bone lesions, with NRS > 4 documented at screening visit
- •Pain from target lesion is distinguishable from other lesions*
- •Target lesion lovation is accessible for MR-HIFU and EBRT**
- •Target lesion is visible om MR or CT imaging obtained < 3 months prior to screening, with a maximum diameter of 8 cm.
- •Reasonable performance score (KPS > 50% or ECOG <3)
- •Life expectancy > 3 months as determined by the study PI or referring oncologist
- •Ability to understand and the willingness to personally sign the written IRB-approved informed consent document
- •Solitary painful metastatic bone lesion or multiple metastatic lesions with one predominantly painful target lesion (≥2 points higher pain score than other lesions).
- •e.g.: Extremities, pelvis (os pubis, os ilium, os ischium, sacrum, acetabulum), shoulders, in selected cases ribs and sternum
排除标准
- •Previous surgery, radiation, HIFU, or other local therapy on the target location
- •Neurological symptoms due to nerve involvement of target lesion
- •Need for surgery of targeted location due to (impending) pathological fracture
- •Unavoidable critical structures or dense tissues in target area*
- •Curative intention of treatment plan
- •Patients with contraindication for MR imaging such as implanted metallic devices that are not MRI - safe, size limitations, claustrophobia, etc.
- •Patients with known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease (GFR <30mL/min/1.73 m^2) or on dialysis
- •Pregnant and nursing patients will be excluded from the study because of a contraindication to administering MRI contrast agents to these patients
- •Patients unable to receive general anesthesia, as determinded by anesthesiologist, study PI or referring oncologist
- •Individuals who are not able or willing to tolerate the required prolonged stationary position during treatment (can be up to 4 hrs of total table time) via self report
- •Participant enrolled in another clinical interventional study related to bone metastases treatment or pain relief treatment
- •Clinically relevant medical history or physical findings that could interfere with the patient's safety as judged by the treating physician
- •as judged by the operator. e.g.: nerve bundles, skin, extensive scarring, non-targeted bones, air (e.g. hollow viscera), (external) fixation device
结局指标
主要结局
Number of participants that achieve a complete response (CR) or partial response (PR)
时间窗: 14 days after treatment
Complete response (CR): Complete response is defined as a pain score of zero at the treated site with no concomitant increase in analgesic intake (stable or reducing analgesics in daily oral morphine equivalents). Partial Response (PR): Partial response is to be defined as any of the following: Pain reduction of 2 or more points at the treated site on a 0-10 scale without analgesic increase; or analgesic dose reduction of 25% or more in daily morphine equivalent from baseline without an increase in pain.
次要结局
- Physician-reported adverse events(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Patient-reported quality of life - PGIC(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Patient-reported pain scores - Pain Diary(1 month)
- Patient-reported quality of life - EORTC QLQ-BM22(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Patient-reported pain scores - BPI (Brief Pain Inventory)(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Anxiety and depression scores(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Patient-reported quality of life - EORTC QLQ-C15-PAL(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Patient-reported quality of life - EQ-5D-5L(on baseline, at 2 and 4 weeks, and at 3 and 6 months)
- Local tumor control(3 and 6 months after completion of treatment)