Fluorescence-guided Resection in Breast Cancer

• Status: Terminated
• Trial end date: 2012-12-20
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: photonamic GmbH & Co. KG

Criteria

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