Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion

Early Phase 1

Recruiting

• Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm
• Interventions: Biological: Alteplase; Drug: Placebo Administration

• Registration Number: NCT06184321
• Lead Sponsor: M.D. Anderson Cancer Center

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 blood clots and is used to treat heart attacks, strokes, and clots in the lungs. Alteplase may help to control symptoms of breathlessness.

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-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.

Study Timeline

• Study Start: 2023-08-17
• Study First Submitted: 2023-12-14
• Study First Submitted QC: 2023-12-14
• Study First Posted: 2023-12-28
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-05
• Last Update Posted: 2025-06-10
• Primary Completion: 2027-02-02
• Study Completion: 2027-02-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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 Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arm I (alteplase)	Alteplase	Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.
Arm II (placebo)	Placebo Administration	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.

Primary Outcome Measures

Name	Time	Method
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events	through study completion; an average of 1 year

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States