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Fluorescence-guided Resection in Breast Cancer

This study has suspended participant recruitment.
(Insufficient recruitment)
Information provided by (Responsible Party):
photonamic GmbH & Co. KG Identifier:
First received: April 22, 2010
Last updated: December 20, 2012
Last verified: December 2012
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.

Condition Intervention Phase
Breast Tumour
Drug: PD L 506
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue

Resource links provided by NLM:

Further study details as provided by photonamic GmbH & Co. KG:

Primary Outcome Measures:
  • Fluorescence intensity in breast cancer tissue [ Time Frame: 3 h after intake of study medication ]

Secondary Outcome Measures:
  • Laboratory data and adverse events [ Time Frame: 14 days ]

Estimated Enrollment: 16
Study Start Date: April 2010
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PD L 506 2nd dose
Different dosage
Drug: PD L 506
Two different doses will be compared
Experimental: PD L 506 Drug: PD L 506
Two different doses will be compared


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01110954

Munich, Germany
Sponsors and Collaborators
photonamic GmbH & Co. KG
  More Information

Responsible Party: photonamic GmbH & Co. KG Identifier: NCT01110954     History of Changes
Other Study ID Numbers: MK01
Study First Received: April 22, 2010
Last Updated: December 20, 2012

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on March 24, 2017