Thoracentesis vs Pleuroscopy for Cancer

(PERFECT-MPE Trial)

Recruiting at 1 trial location

Overseen By Udit Chaddha, MBBS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Known malignant effusion, Terminal illness, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

98 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether thoracentesis or pleuroscopy diagnoses cancer-related fluid in the chest more quickly and effectively. Thoracentesis uses a needle to remove fluid, while pleuroscopy employs a small camera for a closer examination and tissue sampling. Suitable candidates for this trial include individuals with suspected cancer-related fluid buildup in the chest, as indicated by specific scans. The trial will compare the speed of diagnosis and treatment initiation for each method. As an unphased trial, it provides patients the chance to contribute to significant research that could enhance diagnostic methods for cancer-related conditions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these procedures are safe for patients with suspected malignant pleural effusions?

Research has shown that pleuroscopy is generally safe for patients. Minor issues, such as mild bleeding or infection, occur in about 2% to 5% of cases. Serious complications are very rare, with death rates below 0.1%.

Thoracentesis is also well-tolerated and often performed with ultrasound guidance to enhance safety. This common procedure removes fluid buildup in the chest, and most patients experience no significant problems.

Both treatments are considered safe, with only minor risks involved. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two techniques for managing fluid around the lungs due to cancer: pleuroscopy and thoracentesis. Unlike thoracentesis, which uses a needle to drain fluid, pleuroscopy allows doctors to directly look inside the chest cavity, potentially offering more accurate diagnosis and treatment. This could lead to better management of the fluid build-up and improve patient comfort. By comparing these methods, researchers hope to determine which technique provides better outcomes and could become a new standard of care for patients with cancer-related pleural effusions.

What evidence suggests that this trial's treatments could be effective for malignant pleural effusions?

This trial will compare pleuroscopy and thoracentesis for diagnosing cancer in patients with malignant pleural effusions. Research has shown that pleuroscopy, which participants in one arm of this trial will undergo first, is highly effective in diagnosing cancer, with over 90% accuracy, particularly for cancers like mesothelioma. It can also detect cancer when other methods, such as fluid tests, fail. Meanwhile, participants in the other arm will undergo thoracentesis first. Thoracentesis involves examining the fluid around the lungs to check for cancer and is often used to relieve symptoms and assist in treatment planning. While both methods are useful, pleuroscopy generally provides a more accurate cancer diagnosis. ^{1 4 6 7 8}

Who Is on the Research Team?

Udit Chaddha, MBBS

Principal Investigator

MOUNT SINAI HOSPITAL

Are You a Good Fit for This Trial?

This trial is for patients who are suspected to have malignant pleural effusions, which is a condition where there's abnormal fluid buildup around the lungs often linked to cancer. Specific eligibility criteria details were not provided.

Inclusion Criteria

I am referred for a procedure to diagnose pleural issues.

I might have fluid in my chest from cancer, shown on scans.

Exclusion Criteria

I am unable to understand or sign the consent form.

Having prior inconclusive/non-diagnostic thoracentesis or pleuroscopy

My pleural effusion is cancerous.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Procedure

Participants undergo either pleuroscopy or thoracentesis as the first diagnostic test

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the initial procedure

6 months

Regular follow-up visits as needed

What Are the Treatments Tested in This Trial?

Interventions

• Pleuroscopy
• Thoracentesis

Trial Overview

The study aims to determine if starting with thoracentesis (fluid removal) or pleuroscopy (biopsy of the lining around the lungs) leads to quicker and more effective diagnosis and initiation of treatment for cancer-related fluid buildup in the chest.

How Is the Trial Designed?

Group I: Pleuroscopy first Active Control 1 Intervention

Participants will undergo pleuroscopy first

Group II: Thoracentesis first Active Control 1 Intervention

Participants will undergo thoracentesis first

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Citations

1.

ncbi.nlm.nih.gov

ncbi.nlm.nih.gov/books/NBK563003/

Pleuroscopy for the Diagnosis of Cancer in Patients ... - NCBI

A pleural aspiration revealed a positive cytology diagnosis of malignancy in 60% of cases and a positive result of mesothelioma in 32% of cases.

2.

respiratory-research.biomedcentral.com

respiratory-research.biomedcentral.com/articles/10.1186/s12931-024-02684-7

Malignant pleural effusion: current understanding and ...

In this context, several studies have reported accuracy exceeding 90% [59, 60], with values close to 100% for MPM [61]. Absolute ...

3.

atsjournals.org

atsjournals.org/doi/10.1164/ajrccm.162.5.ats8-00

Management of Malignant Pleural Effusions

However, studies have shown that 7 to 12% of patients with malignant effusions may be diagnosed by pleural biopsy when fluid cytology is negative (15, 58). ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369215445490

The Impact of Thoracoscopy on the Management of Pleural ...

This retrospective study suggests thoracoscopy increases diagnostic yield for both benign and malignant disease when thoracentesis and closed needle biopsy are ...

5.

ccjm.org

ccjm.org/content/86/2/95

Managing malignant pleural effusion

Median survival after diagnosis is 4 to 9 months, although prognosis varies considerably depending on the type and stage of the malignancy. How ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06892691

Study Details | NCT06892691 | Pleuroscopy First Versus ...

This is a randomized control trial of patients with suspected malignant pleural effusions comparing patients who undergo either pleuroscopy or ...

7.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369210606046

Pleuroscopy for Diagnosis and Therapy for Pleural Effusions

Complication rates are low (2%-5%) and are typically minor (subcutaneous emphysema, bleeding, infection), with mortality rates <0.1%. Therapeutic interventions, ...

8.

journal.chestnet.org

journal.chestnet.org/article/S0012-3692(23)03356-1/fulltext

PLEUROSCOPY IN CHRONIC PLEURAL EFFUSIONS AT A ...

This retrospective study characterizes the safety, efficacy, and outcomes of CPEs that underwent pleuroscopy at large VA academic medical center over an 8-year ...