NCT01765907已完成1 期
Antalgic Treatment of Painful Bone Metastases by US-guided High Intensity Focused Ultrasound (HIFU).
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Theraclion
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3)
研究概览
简要总结
Antalgic treatment of painful bone metastases by US-guided High Intensity Focused Ultrasound (HIFU).
详细描述
Inclusion Criteria
- 18 years of age or older.
- Histologically proven malignancy of primary tumor. Histologic diagnosis may be established from needle biopsy, cytology, or a surgical biopsy or resection. If the nature of the lesion has been previously through biopsy, the lesion to be treated does not require further documentation.
- Metastatic disease documented either by imaging techniques (plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or by histology. Other imaging techniques may be acceptable with the approval of the principal investigator.
- ≤ 3 treatable painful bone metastases.
- "Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite level II analgesic medications.
- Prothrombin time (PT) >50%, Thrombocytes >50x109/L.
- Estimated life expectancy of 3 months or greater, as estimated by the responsible clinician.
- Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU treatment, based on imaging data.
- Agreement from the anaesthetist for a IV conscious sedation
- Signed study-specific informed consent prior to inclusion.
- Negative pregnancy test before inclusion for women of childbearing and or efficient method of contraception.
- Patient with social security coverage. Biphosphonate, chemotherapy or hormone therapy intake should remain stable (if possible) throughout follow-up duration.
Exclusion criteria for subject selection
- Pregnant or lactating women.
- Radiation therapy to the targeted sites within 30 days prior to enrollment.
- Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel, or hollow viscera,
- Targeted tumor located in skull (including facial bones), vertebral body or sternum.
- Site at need for surgical stabilization
- Uncontrolled bleeding disorders.
- Hematologic primary malignancies.
- patient participating in other trials using drugs or devices
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 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
- •• 18 years of age or older.
- •Histologically proven malignancy of primary tumor. Histologic diagnosis may be established from needle biopsy, cytology, or a surgical biopsy or resection. If the nature of the lesion has been previously through biopsy, the lesion to be treated does not require further documentation.
- •Metastatic disease documented either by imaging techniques (plain radiographs, radionuclide bone scans, computed tomography scans and magnetic resonance imaging) or by histology. Other imaging techniques may be acceptable with the approval of the principal investigator.
- •≤ 3 treatable painful bone metastases.
- •"Worst Pain Score" of > 3 on a scale of 10 during a 24-hour period (as scored on the Brief Pain Inventory [BPI] question #3: 0 = no pain; 10 = worst possible pain) despite level II analgesic medications.
- •Prothrombin time (PT) >50%, Thrombocytes >50x109/L.
- •Estimated life expectancy of 3 months or greater, as estimated by the responsible clinician.
- •Targeted tumor clearly visible in B-mode ultrasonography, and accessible to US-HIFU treatment, based on imaging data.
- •Agreement from the anaesthetist for a IV conscious sedation
- •Signed study-specific informed consent prior to inclusion.
- •Negative pregnancy test before inclusion for women of childbearing and or efficient method of contraception.
- •Patient with social security coverage.
排除标准
- •• Pregnant or lactating women.
- •Radiation therapy to the targeted sites within 30 days prior to enrollment.
- •Targeted tumor mass is less than 10 mm from spinal cord, nerve bundles, bladder, bowel, or hollow viscera,
- •Targeted tumor located in skull (including facial bones), vertebral body or sternum.
- •Site at need for surgical stabilization
- •Uncontrolled bleeding disorders.
- •Hematologic primary malignancies.
- •patient participating in other trials using drugs or devices
结局指标
主要结局
To assess safety including adverse and serious adverse events, local and systemic tolerance of HIFU in patients with bone metastasis acoording to the Common Terminology Criteria for Adverse events (CTCAE version 4.3)
时间窗: up to 3 months after HIFU session
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
1 期
Pilot Study for Palliation of Pain in Bone Metastases by MR-HIFUSecondary Malignant Neoplasm of BoneNCT01117246Philips Healthcare2
Unknown
2 期
High-Intensity Focused Ultrasound Focal Ablation in Treating Patients With Progressive Prostate CancerProstate CancerSexual DysfunctionNCT00988130University College London Hospitals26
Unknown
不适用
MR Imaging- Guided High Intensity Focused Ultrasound (HIFU) Therapy of Bone MetastasesBone MetastasesBone NeoplasmBone CancerBone LesionNCT03106675Turku University Hospital30
Unknown
2 期
Non-invasive Focal Therapy for Osteoid OsteomaOsteoma, OsteoidNCT02302651University of Roma La Sapienza60
Unknown
不适用
Stereotactic Body Radiotherapy for Osseous Low Alpha-Beta Resistant Metastases for Pain ReliefBone MetastasesBreast CancerProstate CancerMelanomaRenal Cell CarcinomaNCT04177056Hamilton Health Sciences Corporation40