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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
  Purpose
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: Participant, 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 ]

Enrollment: 8
Actual Study Start Date: May 31, 2010
Study Completion Date: December 20, 2012
Primary Completion Date: July 19, 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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01110954

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

Responsible Party: photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01110954     History of Changes
Other Study ID Numbers: MK01
Study First Received: April 22, 2010
Last Updated: April 3, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on June 23, 2017