Status:
UNKNOWN
EDIT Management Feasibility Trial
Lead Sponsor:
NHS Greater Glasgow and Clyde
Collaborating Sponsors:
Rocket Medical plc
Conditions:
Pleural Effusion, Malignant
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Malignant Pleural Effusion (MPE) is a collection of fluid inside the chest caused by cancer. It is a common medical problem and often causes severe breathlessness. Patients with this condition general...
Eligibility Criteria
Inclusion
- Clinically confident diagnosis of malignant pleural effusion, defined as any of the following:
- Pleural effusion with histocytologically proven pleural malignancy OR
- Pleural effusion in the context of histocytologically proven malignancy elsewhere, without a clear alternative cause for fluid OR
- Pleural effusion with typical features of malignancy with pleural involvement on cross-sectional imaging (CT/MRI)
- Degree of breathlessness for which therapeutic pleural intervention would be offered
- Age \>18 years
- Expected survival \> 3 months
- Written Informed Consent
Exclusion
- Females who are pregnant or lactating
- Clinical suspicion of non-expansile lung for which talc pleurodesis would not be offered
- Patient preference for 1st-line indwelling pleural catheter (IPC) insertion
- Previous ipsilateral failed talc pleurodesis
- Estimated pleural fluid volume ≤ 1 litre, as defined by thoracic ultrasound
- Any contraindication to chest drain or IPC insertion, including:
- Irreversible coagulopathy Inaccessible pleural collection, including lack of suitable IPC tunnel site
- \- Any contraindication to MRI scanning, including:
- Claustrophobia Cardiac pacemaker Ferrous metal implants or retained ferrous metal foreign body Previously documented reaction to Gadolinium-containing intravenous contrast agent Significant renal impairment (eGFR\<30 ml/min)
Key Trial Info
Start Date :
August 28 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03319186
Start Date
August 28 2017
End Date
November 1 2018
Last Update
October 24 2017
Active Locations (1)
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1
Queen Elizabeth University Hospital
Glasgow, United Kingdom