drugset / Trial / NCT06421610

OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.

NCT06421610 ↗

Phase 1 Unknown 20 enrolled Odense University Hospital
NaSingle-groupOpen-labelSupportive care

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).

Timeline

Start
2023-09-15
Primary completion
2024-12-31
Completion
2024-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Cisplatin Other / unclassified 10.5 mg/m2 Intrathecal
Subject Doxorubicin Other / unclassified 2.1 mg/m2 Intrathecal
Subject Oxaliplatin Small molecule 92 mg/m2 Intrathecal