NCT05191498已完成不适用
Intratumoral Holmium Microspheres Brachytherapy for Patients With Pancreatic Cancer; a Single Center, Non-randomized, Feasibility Study in an Open Surgical Setting - the SLOTH1 Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Average tumour dose by SPECT imaging
研究概览
简要总结
This is a feasibility study in which patients with pancreatic cancer are treated with intratumoral holmium microsphere injections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Female or male aged 18 years and over.
- •Diagnosis of primary (borderline) resectable pancreatic cancer by Dutch Pancreatic Cancer Group (DPCG) guidelines:
- •i. 1o-90o contact between tumor and the superior mesenteric artery, celiac axis or common hepatic artery. Or; ii. 90o-270o contact between tumor and superior mesenteric vein or portal vein, without occlusion.
- •iii. The discussion on resectability has to be made in consensus at multidisciplinary meetings/discussions and may overrule the above criteria (i, ii).
- •Patient is deemed eligible for surgical resection of the pancreatic cancer, however, during open surgery a more advanced disease than initially anticipated is found and resection is no longer feasible.
- •Life expectancy of 12 weeks or longer.
- •World Health Organisation (WHO) Performance status 0-
- •One or more measurable lesions of at least 10 mm in the longest diameter by spiral CT or MRI according to the Response Evaluation Criteria in Solid Tumours (RECIST) 1.1 criteria.
- •Negative pregnancy test for women of childbearing potential.
排除标准
- •Radiation therapy within the last 4 weeks before the start of study therapy.
- •Calcifications in the pancreas or tumour that are highly expected to obstruct the needle tract
- •Any unresolved toxicity greater than National Cancer Institute (NCI), Common Terminology Criteria for Adverse Events (CTCAE version 4.0) grade 2 from previous anti-cancer therapy.
- •Leukocytes < 4.0 109/l and/or platelet count < 100 109/l.
- •Significant cardiac event (e.g. myocardial infarction, superior vena cava (SVC) syndrome, New York Heart Association (NYHA) classification of heart disease ≥2 within 3 months before entry, or presence of cardiac disease that in the opinion of the Investigator increases the risk of ventricular arrhythmia.
- •Patient is deemed ineligible for implantation of 166Ho by an expert panel (surgeon, nuclear medicine physician and researcher) due to tumour anatomy or nearby structures.
- •Pregnancy or breast feeding (women of child-bearing potential).
- •Patients suffering from psychic disorders that make a comprehensive judgement impossible, such as psychosis, hallucinations and/or depression.
- •Patients who are declared incompetent.
结局指标
主要结局
Average tumour dose by SPECT imaging
时间窗: At 1 week after intervention
To establish the feasibility of intratumoral implantation of QuiremSpheres® by evaluating the average tumour absorbed dose in Gy calculated on SPECT.
次要结局
- Microsphere distribution by CT(At 1 week after intervention)
- Number of treatment-related adverse events as assessed by CTCAE v4.0(Up to 3 months after intervention)
- Microsphere distribution by MRI(At 1 week after intervention)
- Tumor response by RECIST 1.1(At 3 months after intervention)
研究者
研究点 (2)
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