Actively Recruiting
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
Led by Odense University Hospital · Updated on 2024-05-20
20
Participants Needed
1
Research Sites
67 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Symptomatic malignant pleural effusion visible with bedside ultrasound
- Histologically or cytologically verified malignancy
- CT scan within the last four weeks
- Malignant pleural effusion requiring at least one drainage procedure
- Drainage performed at least 14 days before the first PITAC treatment
- Bidirectional systemic chemotherapy or immunotherapy at least 14 days before first PITAC or no simultaneous systemic chemotherapy or immunotherapy
- ECOG Performance status between 0 and 2
- Life expectancy of at least 3 months
- Age 18 years or older
- Able to speak and read Danish
- Provided written informed consent according to local Ethics Committee requirements
You will not qualify if you...
- History of allergic reaction to cisplatin, other platinum compounds, or doxorubicin
- Renal impairment with GFR less than 40 ml/min
- Myocardial insufficiency classified as NYHA class greater than 2
- Impaired liver function with bilirubin level greater than or equal to 1.5
- Female subjects who are not of non-reproductive potential (not postmenopausal, no hysterectomy or related surgery, and no congenital or acquired condition preventing childbearing)
- Previous intrathoracic chemotherapy, intrathoracic antibody treatment, or chemical pleurodesis
- Any other condition or therapy that may pose risk or interfere with the study according to the investigator's opinion
AI-Screening
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Trial Site Locations
Total: 1 location
1
Odense PIPAC Center, Department of Surgery, Odense University Hospital
Odense, Denmark, 5000
Actively Recruiting
Research Team
P
Pernille Schjødt Hansen, Student
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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