NCT06480955招募中不适用
BOne Metastases REgistry for Patients Undergoing cryoAbLation With curatIve purpoSe
Cardiovascular and Interventional Radiological Society of Europe5 个研究点 分布在 3 个国家目标入组 50 人开始时间: 2025年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 5
- 主要终点
- Local progression-free survival rate
研究概览
简要总结
BOREALIS is a multicentre, prospective, observational cohort study designed to investigate the effectiveness, feasibility, safety and impact on pain and quality of life of curative-intent cryoablation for the treatment of bone metastases in patients with oligometastatic or bone oligo-progressive disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Bone metastases in patients with oligometastatic disease (<5 bone/visceral metastases) or bone oligo-progressive disease (visceral or osseous multi-metastatic disease stable under systemic treatment except 1-3 progressing bone metastases) from solid tumours;
- •Number of target lesions ≤ 3
- •Size of target lesion(s) < 5 cm (largest diameter);
- •Referral to local ablative treatment by multidisciplinary tumour board (MDTB);
- •Treatment by percutaneous cryoablation with curative intent (i.e., complete tumour destruction) assessed as technically feasible by the IR in charge;
- •Procedure performed with a cryoablation system from Boston Scientific.
排除标准
- •< 18 years old;
- •Incapacity or refusal to give informed consent;
- •Ongoing pregnancy;
- •Health status not compatible with the minimum meaningful follow-up period (i.e., 12 months):
- •Karnofsky Performance Scale < 60%, or
- •Bone metastases originating from rapidly evolving tumour histologies not allowing reasonable life expectancy of at least 12 months, or
- •Life expectancy < 12 months
- •Infection of treatment site or systemic infection;
- •Uncorrectable coagulopathy;
- •Haematological disease (including multiple myeloma and plasmacytoma);
- •Concomitant radiation therapy or radiation therapy within 12 weeks before the planned cryoablation procedure.
结局指标
主要结局
Local progression-free survival rate
时间窗: 12 months
On a per lesion basis, proportion of target lesions free from local tumour progression using the Kaplan Meier estimate
次要结局
- Impact on patient quality of life(1, 3, 6, 12 months)
- Technical feasibility(Periprocedurally)
- Fracture-free survival(End of study)
- Fracture-free survival rate(Until the end of the follow-up period (1 year))
- Bone-disease progression-free survival(Until the end of the follow-up period (1 year))
- Overall progression-free survival(Until the end of the follow-up period (1 year))
- Systemic therapy-free survival(Until the end of the follow-up period (1 year))
- Complete local tumour response(12 months)
- Extraosseous disease progression-free survival(Until the end of the follow-up period (1 year))
- Adverse events(Through study completion)
- Overall survival(Until the end of the follow-up period (1 year))
- Impact on patient pain(1, 3, 6, 12 months)
研究者
研究点 (5)
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