Recruiting
Early Phase 1

Alteplase

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT06184321

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Alteplase

Placebo Administration

Study Details

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.

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Malignant Solid Neoplasm

Study ID

NCT06184321

Start date

Aug 17, 2023

Status verified date

Aug, 2026

Completion date

Feb 2, 2027

Anticipated

Primary completion date

Feb 2, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm I (alteplase)

Patients receive alteplase instilled into the IPC which is capped for 1-2 hours before the catheter is drained.

placebo comparator: 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.

Interventions

Alteplase

Instilled into IPC

Placebo Administration

Instilled into IPC

Primary outcome measure

  • Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events [ Time Frame: through study completion; an average of 1 year ]

Central Contacts and Locations

Central contacts

Horiana Grosu, M D

713-792-6238hbgrosu@mdanderson.org

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Horiana Grosu, MD

713-792-6238hbgrosu@mdanderson.org

Principal Investigator:

Horiana Grosu, MD

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 17, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-17.