Trial | NCT01110954  Report issue

Title

Fluorescence-guided Resection in Breast Cancer
Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Intervention/Treatment

    pd l 506 ...

  • Study Participants

    8
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.
Study Started
May 31
2010
Primary Completion
Jul 19
2012
Study Completion
Dec 20
2012
Last Update
Apr 04
2017

Drug PD L 506

Two different doses will be compared

PD L 506 2nd dose Active Comparator

Different dosage

PD L 506 Experimental

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
No Results Posted