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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: Triple (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
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