Evaluation of the suitability of PD L 506 for intraoperative visualisation of palpable and nonpalpable breast cancer tissue

• Conditions: Breast cancer; palpable and non-palpable tumours of the female breast.; MedDRA version: 14.1Level: PTClassification code 10006187Term: Breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

• Registration Number: EUCTR2009-016842-22-DE
• Lead Sponsor: photonamic GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-25
• Last Update Posted: 27 January 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: Not specified

Inclusion Criteria

•Written informed consent has been signed prior to or at Visit 1
•Caucasian female postmenopausal patients
•Patients with histologically confirmed primary palpable and nonpalpable breast cancer, respectively (depending on Step 1 or Step 2) sized up to 5 cm (T1 – T2)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Use of photosensitising drugs e.g. tetracycline or hypericin within 14 days before tumour surgery
•Diagnosis of porphyria
•Suspicious lymphogenic metastases (cN1-3)
•Acute or chronic hepatic diseases (levels of ASAT, ALAT and/or ?GT more than 2.5 times the upper normal limit)
•Manifest renal diseases with renal dysfunction
•Relevant cardiac disease
•Patients with a body weight < 60 kg or > 90 kg
•Preceding therapy of breast tumour under investigation
•Patients with multiple attempts of hook-wire placement in preparation of surgery (only Step 2)
•Known intolerance to study medication
•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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified