Fluorescence-guided Resection in Breast Cancer
Phase 2
Terminated
- Conditions
- Breast Tumour
- Interventions
- Drug: PD L 506
- Registration Number
- NCT01110954
- Lead Sponsor
- photonamic GmbH & Co. KG
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 8
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PD L 506 2nd dose PD L 506 Different dosage PD L 506 PD L 506 -
- Primary Outcome Measures
Name Time Method Fluorescence intensity in breast cancer tissue 3 h after intake of study medication
- Secondary Outcome Measures
Name Time Method Laboratory data and adverse events 14 days