Breast Tumour
Conditions
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.
Interventions
DRUGPD L 506
Two different doses will be compared
Sponsors
photonamic GmbH & Co. KG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Fluorescence intensity in breast cancer tissue | 3 h after intake of study medication |
Secondary
| Measure | Time frame |
|---|---|
| Laboratory data and adverse events | 14 days |
Countries
Germany
Outcome results
None listed