Fluorescence-guided Resection in Breast Cancer

Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue

This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.

Inclusion Criteria:

• Written informed consent
• Caucasian female postmenopausal patients
• Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2)

Exclusion Criteria:

• Suspicious lymphogenic metastases (cN1-3)
• Acute or chronic hepatic diseases
• Manifest renal diseases with renal dysfunction
• Relevant cardiac disease
• Preceding therapy of breast tumour under investigation
• Patients with multiple attempts of hook-wire placement in preparation of surgery
• 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