Fluorescence-guided Resection in Breast Cancer

photonamic

Status and phase: Terminated; Phase 2

Conditions: Breast Tumour

Treatments: Drug: PD L 506

Study type: Interventional

Funder types: Industry

Identifiers

NCT01110954

MK01

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

8 participants in 2 patient groups

PD L 506 2nd dose

Active Comparator group

Description:

Different dosage

Treatment:

Drug: PD L 506

PD L 506

Experimental group

Treatment:

Drug: PD L 506