Implementation and Evaluation of Pressurized Intrathoracic Aerosol Chemotherapy (PITAC) for the Treatment of Patients With Malignant Pleural Effusion. A Danish Phase I Study (OPC5 Study)
This study will monitor and evaluate patient and personnel safety and toxicity during the implementation and evaluation of Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) directed treatment. Furthermore, this study will focus on Quality of Life questionnaires, LENT score, and evaluate pain and breathlessness using af visual analogue scales (VAS).
• Symptomatic MPE visible with bedside ultrasound
• Histologically or cytologically verified malignancy
• Status CT-scan not older than four weeks
• MPE requiring at least one drainage procedure
• Drained ≥ 14 days before the first PITAC directed treatment
• Bidirectional systemic chemotherapy or immunotherapy ≥ 14 days before the first PITAC directed treatment or no simultaneous systemic chemotherapy or immunotherapy
• ECOG Performance status 0-2
• Life expectancy ≥ 3 months
• Age ≥ 18 years
• Danish-speaking and reading patients
• Written informed consent according to the local Ethics Committee requirements