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Fluorescence-guided Resection in Breast Cancer

This study has suspended participant recruitment.
(Insufficient recruitment)
Sponsor:
Information provided by (Responsible Party):
photonamic GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01110954
First received: April 22, 2010
Last updated: December 20, 2012
Last verified: December 2012
  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
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory data and adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 16
Study Start Date: April 2010
Primary Completion Date: December 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
Genders 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

No publications provided

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: December 20, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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

ClinicalTrials.gov processed this record on November 25, 2014