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Fluorescence-guided Resection in Breast Cancer

This study has been terminated.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01110954
First received: April 22, 2010
Last updated: April 3, 2017
Last verified: April 2017

April 22, 2010
April 3, 2017
May 31, 2010
July 19, 2012   (Final data collection date for primary outcome measure)
Fluorescence intensity in breast cancer tissue [ Time Frame: 3 h after intake of study medication ]
Same as current
Complete list of historical versions of study NCT01110954 on ClinicalTrials.gov Archive Site
Laboratory data and adverse events [ Time Frame: 14 days ]
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
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
8
December 20, 2012
July 19, 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
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01110954
MK01
No
Not Provided
Not Provided
Not Provided
photonamic GmbH & Co. KG
photonamic GmbH & Co. KG
Not Provided
Not Provided
photonamic GmbH & Co. KG
April 2017

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