NCT06421610 OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
| NCT ID | NCT06421610 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Odense University Hospital |
| Condition | Malignant Pleural Effusion |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-09-15 |
| Primary Completion | 2024-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * A history of allergic reaction to cisplatin or other platinum containing compounds or doxorubicin * Renal impairment, defined as GFR \< 40 ml/min (Cockcroft-Gault Equation) * Myocardial insufficiency, defined as NYHA class \> 2 * Impaired liver function defined as bilirubin ≥1.5 * Fertility, pregnancy and lactation: Female subjects will be