Breast Tumour Clinical Trial
Official title:
Evaluation of the Suitability of PD L 506 for Intraoperative Visualisation of Palpable and Nonpalpable Breast Cancer Tissue
| Verified date | April 2017 |
| Source | photonamic GmbH & Co. KG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 8 |
| Est. completion date | December 20, 2012 |
| Est. primary completion date | July 19, 2012 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| photonamic GmbH & Co. KG |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Fluorescence intensity in breast cancer tissue | 3 h after intake of study medication | ||
| Secondary | Laboratory data and adverse events | 14 days |