2025-524123-45-00招募中2 期
Treatment of low-flow vascular malformations with bleomycin electrosclerotherapy (BEST)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.
研究概览
简要总结
To determine the efficacy and feasibility of BEST in the treatment of low-flow vascular malformations.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients with low-flow vascular malformations (venous, lymphatic, capillary or mixed type malformations),
- •Patients with a low-flow vascular malformation poorly responding or recurring after previous treatment(s).
- •Technical feasibility of the BEST procedure, i.e.: injection of bleomycin and safe placement of electrodes into the vascular malformation are technically feasible.
- •longer lesion diameter not exceeding 25 cm.
- •more than one lesion can be treated. The limiting factor is the maximal dose per patient per treatment session; 10 000 IU in adults,
- •skin or mucosal, superficial or deep-seated lesions can be treted,
排除标准
- •Pregnancy and lactation
- •chronic renal dysfunction.
- •in adults, previous bleomycin exposure with a cumulative dose greater than 100 000 IU. In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated,
- •In case of abnormal respiratory results/chest pathology (including previous severe or long COVID) in consultation with a pulmonologist, special care is required, and bleomycin exposure may be contraindicated.
- •Known allergy or hypersensitivity to bleomycin.
- •Presence of significant central venous drainage precluding sclerotherapy.
- •women of childbearing potential and men not using reliable contraceptive,
- •acute lung infection or severely reduced lung function,
- •bleomycin-related lung toxicity or reduced lung function which can indicate bleomycin-related lung toxicity,
- •ataxia telangiectasia,
研究组 & 干预措施
Bleomycin medac, 15 000 RÜ süstelahuse pulber
Test
干预措施: Bleomycin medac, 15 000 RÜ süstelahuse pulber (Drug)
结局指标
主要结局
To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.
To evaluate effectiveness of BEST in reducing lesion volume, as measured by MRI 3 months after the treatment in patients with low-flow vascular malformations.
次要结局
- Assessment of the effectiveness of BEST 12 months after the treatment.
- Feasibility of recruitment and treatment according to the Current Operating Procedures
- Safety and tolerability: Incidence, severity and relationship of treatment-emergent adverse events classified accordint to MedDRA and graded using CTCEA v5.0
- Quality of life: QoL assessment with clinically validated OVAMA questioner.
研究者
Gregor Serša
Scientific
Institute Of Oncology Ljubljana
研究点 (1)
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