Breast cancer
Conditions
Interventions
Trade Name: Gliolan 30 mg/ml powder for oral solution
Product Name: Gliolan 30 mg/ml powder for oral solution
Product Code: PD L 506
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN:
Sponsors
photonamic GmbH & Co. KG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The study is composed of two consecutive study steps. Only if Step 1 is successfully completed, Step 2 will be performed. Primary Study Aims: •Step 1: Assessment and quantitative determination of PPIX fluorescence in palpable breast cancer tissues after oral administration of PD L 506 for implementation of the technical setting serving as prerequisite for Step 2. •Step 2: Assessment and quantitative determination of PPIX fluorescence in nonpalpable breast cancer tissue after oral administration of one of two different doses of PD L 506. ;Secondary Objective: •Examination of margins of the instantaneous tumour sections and the surgical cavity using PPIX fluorescence •Assessment of PPIX fluorescence of the sentinel lymph node (SLN) •Assessment of safety and tolerability of study medication ;Primary end point(s): Both Steps: Mean PPIX fluorescence intensity in breast cancer tissue: •Qualitative assessment by the investigator: none/weak/strong •Histological evaluation of breast cancer tissue in comparison with non-malignant tissue with respect to PPIX fluorescence •Photo and video documentation •Determination of PPIX concentration by fluorescence spectrometry | — |
Countries
Germany
Outcome results
None listed