Status:
RECRUITING
Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
Lead Sponsor:
M.D. Anderson Cancer Center
Conditions:
Hematopoietic and Lymphoid Cell Neoplasm
Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
This study investigates whether alteplase can help to improve pleural fluid drainage and dyspnea (breathlessness) in patients with non-draining malignant pleural effusion. Alteplase helps dissolve blo...
Detailed Description
PRIMARY OBJECTIVE: I. To evaluate dyspnea using the visual analog scale (VAS) scale at one week in patients with symptomatic septated malignant neoplasm of the pleural effusion (MPE) and a non-draini...
Eligibility Criteria
Inclusion
- Referral to pulmonary services for inability to drain fully via IPC
- Presence of a symptomatic septated pleural effusion
- A pleural effusion of significant moderate to large volume based on:
- Chest radiograph: effusion filling \>= 1/3 of the hemithorax, or
- Computed tomography (CT)-scan: AP depth of the effusion \>= 1/3 of the AP dimension on the axial image superior to the hemidiaphragm, including atelectatic lung surrounded by effusion, or
- Ultrasound: effusion spanning at least three intercostal spaces, with a \>= 3 cm in at least one intercostal space, while the patient sits upright
- Age \> 18
- Borg score \>= 3
- Absence of a blocked IPC as demonstrated by a flush with 20 cc of saline x1 without resistance
- Presence of septated effusion based on ultrasound (US) and chest CT
Exclusion
- Inability to provide informed consent
- Study subject has any disease or condition that interferes with safe completion of the study including:
- Uncorrectable coagulopathy based on criteria followed by cardiopulmonary center for procedures.
- Active bleeding
- Known allergic reaction to thrombolytics
- Pleural effusion is smaller than expected on bedside pre-procedure ultrasound
- No septations and/or no loculations on bedside pre-procedure ultrasound
- Patient is asymptomatic
- Blocked IPC as determined by saline flush
Key Trial Info
Start Date :
August 17 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06184321
Start Date
August 17 2023
End Date
February 2 2027
Last Update
December 26 2025
Active Locations (1)
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1
M D Anderson Cancer Center
Houston, Texas, United States, 77030