Evaluation of the suitability of PD L 506 for intraoperative visualisation of palpable and nonpalpable breast cancer tissue

photonamic GmbH & Co. KG0 个研究点开始时间: 2010年1月25日最近更新: 2014年1月27日

适应症

试验速览

暂无简介。

•Written informed consent has been signed prior to or at Visit 1
•Caucasian female postmenopausal patients
•Patients with histologically confirmed primary palpable and nonpalpable breast cancer, respectively (depending on Step 1 or Step 2) sized up to 5 cm (T1 – T2)
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Use of photosensitising drugs e.g. tetracycline or hypericin within 14 days before tumour surgery
•Diagnosis of porphyria
•Suspicious lymphogenic metastases (cN1-3)
•Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or ?GT more than 2.5 times the upper normal limit)
•Manifest renal diseases with renal dysfunction
•Relevant cardiac disease
•Patients with a body weight < 60 kg or > 90 kg
•Preceding therapy of breast tumour under investigation
•Patients with multiple attempts of hook-wire placement in preparation of surgery (only Step 2)
•Known intolerance to study medication
•Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
•Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment

发起方