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Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Tumour

Thank you

Trial Information

Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Outcome Measure:

Fluorescence intensity in breast cancer tissue

Outcome Time Frame:

3 h after intake of study medication

Safety Issue:

No

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

MK01

NCT ID:

NCT01110954

Start Date:

April 2010

Completion Date:

Related Keywords:

  • Breast Tumour
  • Breast Neoplasms

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