Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06421610
Status:
RECRUITING
Last Update Posted:
2024-05-20
First Post:
2023-04-26
Brief Title:
OPC5 Pressurized IntraThoracic Aerosol Chemotherapy PITAC in Patients With Malignant Pleural Effusion
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
This is a safety and feasibility study of repeated minimum two procedures PITAC directed treatments and the primary outcome is the number of patients with medical adverse events AEs according to the Common Terminology Criteria for Adverse Events CTCAE andor surgical complications according to the Clavien-Dindo classification This study will include consecutive MPE patients until 20 patients have completed at least two PITACs The PITAC directed treatment will be performed in 4 week intervals Bedside ultrasound VAS-pain and VAS-breathlessness and Quality of Life questionnaires will be performed at baseline one month follow-up and three months follow-up
Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor MDT conference at the Department of Surgery Odense University Hospital OUH and included based on predefined in- and exclusion criteria Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin
In brief The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy PITAC is performed in the prone or lateral position A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung but this is not always necessary with the patient in the prone position The first trocar is placed guided by ultrasound and after safe positioning a second trocar can be inserted guided by video thoracoscopy The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector After five minutes the chemotherapy has been delivered to the pleural cavity and after an additional 30 minutes of simple diffusion the intrathoracic air saturated with chemotherapy is evacuated through a series of filters
The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events
Patients with MPE who are eligible for surgery are identified during the multidisciplinary tumor MDT conference at the Department of Surgery Odense University Hospital OUH and included based on predefined in- and exclusion criteria Patients with MPE from non-colorectal or -appendix cancer will be treated with a combination of cisplatin and doxorubicin Patients with MPE from colorectal or appendix cancer will be treated with oxaliplatin
In brief The PITAC procedure is the application of aerosolized chemotherapy into the pleural cavity using thoracoscopy PITAC is performed in the prone or lateral position A double lumen endotracheal tube is used to allow exclusion of the ipsilateral lung but this is not always necessary with the patient in the prone position The first trocar is placed guided by ultrasound and after safe positioning a second trocar can be inserted guided by video thoracoscopy The chemotherapy is applied to the pleural cavity through a nebulizer inserted through one of the trocars and linked to a high-pressure injector After five minutes the chemotherapy has been delivered to the pleural cavity and after an additional 30 minutes of simple diffusion the intrathoracic air saturated with chemotherapy is evacuated through a series of filters
The patients are monitored for a minimum of one day and will after each PITAC directed treatment be screened for adverse events
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None