EUCTR2011-003194-28-DE进行中（未招募）不适用
Determination of the sensitivity of ICG fluorescence technique for the detection of Sentinel Lymph Nodes in breast cancer – a monocenter, prospective open-label clinical trial - PULSION-001
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Early breast cancer: histopathologically confirmed diagnosis, maximum tumour stage T1 and T2, therefore diameter < 5 cm, unifocal tumour or multifocal tumour Grading G1-G3
- •Indicated sentinel lymph node biopsy as part of the patient’s routine management for breast cancer
- •Age: 18 – 80 years, inclusive
- •Gender: male and female
- •General operability
- •Intact site-specific anatomy at the concerned breast and /or axilla for ensuring an adequate lymphangiography
- •if a performance of investigations with radioactive traced iodide is planed, this has to be performed at least 1 week before or 1 week after ICG application
- •No clinically significant findings in the routine blood examinations
- •Female subjects must be either at least two years postmenopausal or must have a negative pregnancy test prior to Tc application and must use a highly effective means of birth control (birth control that, alone or in combination, result in a low failure rate of less than 1% per year when used consistently and correctly):
- •hormonal method of contraceptive,
- •surgical sterility,
- •double barrier methods,
- •intrauterine contraceptive device,
- •lifestyle with a personal choice of abstinence,
- •bilateral vasectomy of sexual partner at least 3 months prior to
- •enrolment in combination with barrier methods
- •Willing and able to complete screening and study procedures, as described in the protocol
- •Signed written informed consent to participate in this clinical trial
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 125
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 125
排除标准
- •Breast cancer: stage T3 or T4 carcinoma, inflammatory or exulcerated mamma carcinoma
- •Former operation in axilla
- •Any previous radiotherapy at the concerned breast and / or axilla and / or chestwall
- •Definite lymph node metastases (ultrasound and / or fine-needle aspiration) (definite nodal positive patients in fine-needle aspiration)
- •Contraindication for technetium imaging
- •History of allergy or hypersensitivity against the investigational medicinal products (its active substance or ingredients)
- •History of intolerability to ICG-Pulsion® during a previous injection, as this may lead to serious anaphylactic reactions
- •History of allergic diseases / hypersensitivities, unless the investigator considers the allergic disease as clinically irrelevant for the purpose of this clinical trial
- •Allergy to iodine or to shellfish
- •Any other contraindication to one of the investigational medicinal products as described in their Summary of Product Characteristics
- •Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or disseminated autonomies of the thyroid gland
- •Advanced renal impairment (creatinine > 1,5mg/dl)
- •Complete lymphatic obstruction
- •All clinically relevant internal medicinal diseases, cardiac or renal that could impair the outcome of the clinical trial or that in the investigator’s mind are not compatible with participation for medical reasons
- •Acute inflammatory or febrile illness
- •Evidence of local inflammation at the site of surgery
- •Concurrent medication or any medication during the 2 weeks preceeding the enrolment which reduce or increase the extinction of ICG (i.e. anticonvulsants, haloperidol)
- •Current or recent history of illicit drug or alcohol abuse, or dependence as defined as the continued use of alcohol or drugs despite the development of social, legal, or health problems
- •Psychiatric or cognitive impairment that, in the opinion of the investigator, would interfere with the subject’s ability to comply with the study requirements (e.g. Alzheimer’s disease)
- •Pregnancy, breastfeeding
- •Inability to understand the nature and the extent of the trial and the procedures required
- •Missing signed written informed consent to participate in the clinical trial
- •Participation in a drug trial during the whole clinical trial
研究者
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