Thorakoskopische Handheld-SPECT Gesteuerte Ektomie Von Radioaktiv-markierten Pulmonalen Rundherden. Proof of Feasibility of Thoracoscopic Ectomy of Radioactively Marked Pulmonary Nodules With the Help of Free-hand SPECT.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Successful thoracoscopic ectomies
研究概览
简要总结
Title ThoHSpEkt
Study Design Pilot Study concerning the technical operative methods and a phase II study concerning the radiopharmaceutical (therapeutic-explorative study with an approved drug in a new indication)
Location Kantonsspital St.Gallen
Aim Proof of feasibility of thoracoscopic ectomy of radioactively marked pulmonary nodules with the help of free-hand SPECT.
Background In the Cantonal Hospital of St.Gallen an average of 30 - 40 patients will be operated with thoracoscopic ectomy for a pulmonary nodule. When localisation of the nodule is not possible a switch to minithoracotomy is performed.
Study intervention Marking of pulmonary nodules with radioactivity. Free-hand SPECT guided surgery
Risks Risks of bronchoscopic or CT-intervention Radiation risk (minimal)
Rational for patient number 10 patients for each group are enough to prove the feasibility, to manage difficulties and to record complications
Duration approximately 24 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Investigator)
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 over 18 years
- •Planed thoracoscopic surgery of a pulmonary nodule
- •Informed consent
排除标准
- •mental incapacity
- •contraindications for this treatment
- •pregnancy
研究组 & 干预措施
CT guided labelling
CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
干预措施: Radioactive labelling of pulmonary nodules (Drug)
CT guided labelling
CT guided radioactive labelling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
干预措施: CT guided radioactive labelling (Device)
Electromagnetic bronchoscopic labelling
Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
干预措施: Radioactive labelling of pulmonary nodules (Drug)
Electromagnetic bronchoscopic labelling
Electromagnetic guided bronchoscopic labeling of pulmonary nodules followed by handheld-SPECT guided thoracoscopic surgery.
干预措施: Electromagnetic guided bronchoscopic radioactive labelling (Device)
结局指标
主要结局
Successful thoracoscopic ectomies
时间窗: 1 week
Rate of successful thoracoscopic ectomies (i.e. without reversion to (mini-)thoracotomy and without any complications)
次要结局
- CT labelling(1 day)
- CT Labelling complications(1 day)
- Successful labeling using electro-magnetically navigated bronchoscopy(1 day)
- Complications after labeling using electro-magnetically navigated bronchoscopy(1 day)
研究者
Joachim Müller
Head of Department
Cantonal Hospital of St. Gallen