Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
NCT ID: NCT06184321
Last Updated: 2025-12-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
EARLY_PHASE1
30 participants
INTERVENTIONAL
2023-08-17
2027-02-02
Brief Summary
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Detailed Description
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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-draining/inadequately draining indwelling pleural catheter (IPC).
SECONDARY OBJECTIVE:
I. To evaluate dyspnea using the visual analog scale (VAS) scale at 48 hours (+/-12 hours) after treatment with intrapleural alteplase, in patients with septated MPE and a nondraining/inadequately draining IPC. In addition, complications, quality adjusted survival (calculated using the SF-6D to determine utilities and then integrating utilities over time to arrive at quality-adjusted survival), change in dyspnea (using the Borg score and VAS scale) at 1 week (+/- 1 day), 2 weeks (+/- 2 days) and every 4 weeks (+/- 2 days) after the intervention until IPC removal or death.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
ARM II: Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.
Conditions
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Study Design
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RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Arm I (alteplase)
Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
Alteplase
Instilled into IPC
Arm II (placebo)
Patients receive placebo instilled into the IPC which is capped for 1-2 hours before the catheter is drained. Beginning 1 week later, patients may receive alteplase as in arm I.
Placebo Administration
Instilled into IPC
Interventions
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Alteplase
Instilled into IPC
Placebo Administration
Instilled into IPC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* 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
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Horiana Grosu, M D
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Horiana Grosu, MD
Role: primary
Related Links
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M D Anderson Cancer Center
Other Identifiers
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NCI-2021-09122
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-0554
Identifier Type: OTHER
Identifier Source: secondary_id
2021-0554
Identifier Type: -
Identifier Source: org_study_id