Clinical Trial Radar

The clinical trial identified as NCT01110954 was an exploratory Phase II study focused on improving the surgical removal of breast tumors using a specialized diagnostic agent.

📋 Trial Overview: Fluorescence-guided Resection in Breast Cancer

This study, sponsored by photonamic GmbH & Co. KG, investigated the use of the drug PD L 506 to help surgeons better visualize breast tumor tissue during an operation. This technique is known as fluorescence-guided surgery.

🔬 Key Terminology and Mechanism

The core concept of this trial is fluorescence-guided resection.

• PD L 506: This is the investigational drug designed to be taken up selectively by tumor cells. Once inside the cells, it is expected to fluoresce (glow) when exposed to a specific wavelength of light.
• Intra-operative Detection: This means the agent is used during the surgery to help the surgeon distinguish between cancerous tissue and healthy tissue in real-time. The goal is to ensure that the entire tumor is removed while sparing as much healthy tissue as possible.

🧪 Study Design and Methodology

This was a small, exploratory Phase II study, meaning it was designed to gather preliminary data on the effectiveness and safety of the diagnostic agent.

• Design: The study utilized a Randomized, Parallel design, comparing two different doses of PD L 506.
• Masking: It was Triple Masked (or Triple Blinded), meaning the participant, the investigator (the surgeon/researcher), and the outcomes assessor (the person evaluating the results) were all unaware of which dose the participant received. This high level of blinding helps reduce bias in the results.
• Primary Outcome: The main measurement was the Fluorescence intensity in breast cancer tissue three hours after the patient took the study medication. Researchers needed to confirm that the tumor glowed significantly brighter than the surrounding healthy tissue.

✅ Eligibility Requirements

The study targeted a very specific patient population:

• Sex and Age: Female patients, minimum age 18 years.
• Menopausal Status: Postmenopausal.
• Ethnicity: Caucasian.
• Condition: Histologically confirmed primary breast cancer, sized up to 5 cm (T1 or T2 stage), and palpable or nonpalpable.

Key Exclusions included patients who had already received treatment for the breast tumor under investigation, those with suspicious lymph node involvement (cN1-3), or those with significant pre-existing hepatic, renal, or cardiac diseases.

💡 Importance of the Study

While this study was terminated with a very small enrollment (8 participants), the research area it addressed—improving surgical margins in breast cancer—remains critical. Achieving clear surgical margins (meaning no cancer cells are left at the edge of the removed tissue) is essential for reducing the risk of recurrence. Diagnostic agents like PD L 506 aim to provide surgeons with better tools than visual inspection alone to achieve this precision.

📢 Important Notice: This trial is listed as TERMINATED and completed data collection in December 2012. If you are considering participation in any clinical research, always consult with your healthcare provider to discuss the risks and benefits relative to your personal health situation.

One trial matched filter criteria.