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Fluorescence-guided Resection in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01110954
Recruitment Status : Terminated (Insufficient recruitment)
First Posted : April 27, 2010
Last Update Posted : April 4, 2017
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG

Tracking Information
First Submitted Date  ICMJE April 22, 2010
First Posted Date  ICMJE April 27, 2010
Last Update Posted Date April 4, 2017
Actual Study Start Date  ICMJE May 31, 2010
Actual Primary Completion Date July 19, 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Fluorescence intensity in breast cancer tissue [ Time Frame: 3 h after intake of study medication ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01110954 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 23, 2010)
Laboratory data and adverse events [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Fluorescence-guided Resection in Breast Cancer
Official Title  ICMJE Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Tumour
Intervention  ICMJE Drug: PD L 506
Two different doses will be compared
Study Arms  ICMJE
  • Active Comparator: PD L 506 2nd dose
    Different dosage
    Intervention: Drug: PD L 506
  • Experimental: PD L 506
    Intervention: Drug: PD L 506
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 3, 2017)
8
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2010)
16
Actual Study Completion Date  ICMJE December 20, 2012
Actual Primary Completion Date July 19, 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01110954
Other Study ID Numbers  ICMJE MK01
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party photonamic GmbH & Co. KG
Study Sponsor  ICMJE photonamic GmbH & Co. KG
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account photonamic GmbH & Co. KG
Verification Date April 2017

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