Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 22, 2010
December 20, 2012
April 2010
December 2012   (final data collection date for primary outcome measure)
Fluorescence intensity in breast cancer tissue [ Time Frame: 3 h after intake of study medication ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01110954 on Archive Site
Laboratory data and adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
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.

Not Provided
Phase 2
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Breast Tumour
Drug: PD L 506
Two different doses will be compared
  • Active Comparator: PD L 506 2nd dose
    Different dosage
    Intervention: Drug: PD L 506
  • Experimental: PD L 506
    Intervention: Drug: PD L 506
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Not Provided
December 2012   (final data collection date for primary outcome measure)

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
18 Years and older
Contact information is only displayed when the study is recruiting subjects
photonamic GmbH & Co. KG
photonamic GmbH & Co. KG
Not Provided
Not Provided
photonamic GmbH & Co. KG
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP