NCT06184321 Alteplase Through an Indwelling Pleural Catheter for the Management of Symptomatic Septated Malignant Pleural Effusion
| NCT ID | NCT06184321 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | M.D. Anderson Cancer Center |
| Condition | Hematopoietic and Lymphoid Cell Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-17 |
| Primary Completion | 2027-02-02 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2023-08-17 with a primary completion date of 2027-02-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Horiana Grosu, M D
PRINCIPAL INVESTIGATOR
M.D. Anderson Cancer Center
Frequently Asked Questions
Who can join the NCT06184321 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hematopoietic and Lymphoid Cell Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06184321 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06184321 currently recruiting?
Yes, NCT06184321 is actively recruiting participants. Contact the research team at hbgrosu@mdanderson.org for enrollment information.
Where is the NCT06184321 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06184321 clinical trial?
NCT06184321 is sponsored by M.D. Anderson Cancer Center. The principal investigator is Horiana Grosu, M D at M.D. Anderson Cancer Center. The trial plans to enroll 30 participants.