Diagnostic Lab Test During Pleuroscopy for Lung Cancer

No longer recruiting at 3 trial locations

Overseen By Horiana Grosu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Known malignant pleural effusion, others

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

Approved in 5 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a specific lab test in diagnosing fluid buildup between the lung linings, known as malignant pleural effusion. The test uses samples collected during a scheduled pleuroscopy. Participants are those already set to undergo pleuroscopy with a biopsy and thoracoscopy (also known as Video-Assisted Thoracoscopic Surgery or VATS, a minimally invasive procedure). The trial excludes individuals who already have a confirmed diagnosis of malignant pleural effusion. As an unphased trial, it offers patients the chance to contribute to medical research and potentially enhance diagnostic methods for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this diagnostic lab test is safe for diagnosing malignant pleural effusion?

Research has shown that thoracoscopy, particularly with video-assisted thoracoscopic surgery (VATS), is generally safe and well-tolerated. Studies have found that VATS can reduce the risk of death by 21% for lung cancer patients compared to more invasive surgeries. As a minimally invasive technique, it typically allows for faster recovery and less pain.

Most patients undergoing VATS experience fewer complications than those having traditional open surgery. Overall, evidence supports thoracoscopy as a reliable and safe option for lung-related procedures. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using thoracoscopy during pleuroscopy for lung cancer because it offers a unique and minimally invasive way to biopsy the lung lining. Unlike traditional surgical biopsies, this technique allows doctors to directly view and collect tissue from the lung's pleura with minimal discomfort and faster recovery for patients. This approach not only provides more accurate diagnostic information but also reduces the risks associated with open surgical procedures, making it a promising advancement in lung cancer diagnosis.

What evidence suggests that this diagnostic lab test is effective for diagnosing malignant pleural effusion?

Research has shown that thoracoscopy, a type of surgery performed with small incisions, effectively identifies and treats lung problems. Studies have found that it can extend the lives of people with lung cancer compared to non-surgical treatments. Video-assisted thoracoscopic surgery (VATS), a common method of thoracoscopy, is associated with better patient outcomes, such as reduced pain and faster recovery. In this trial, participants will undergo pleuroscopy, a form of thoracoscopy, primarily for diagnostic purposes. Thoracoscopy has a strong history in lung procedures, making it a reliable choice for diagnosing malignant pleural effusion, which is cancerous fluid in the lung lining. ^{3 5 6 7 8}

Who Is on the Research Team?

Horiana Grosu

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for patients who are scheduled to undergo pleuroscopy with biopsy to check for cancerous fluid in the lung linings. It's not open to those already diagnosed with malignant pleural effusion or those who can't or won't consent.

Inclusion Criteria

I am scheduled for a pleuroscopy with biopsy.

Exclusion Criteria

Inability or unwillingness to give informed consent

I have fluid in my chest from cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pleuroscopy and Biopsy

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after pleuroscopy and biopsy

Up to 1 year

What Are the Treatments Tested in This Trial?

Interventions

• Biopsy
• Medical Chart Review
• Thoracoscopy

Trial Overview The study tests a lab technique called rapid on site evaluation of pleural touch preparations, using samples from biopsies taken during pleuroscopy, to diagnose malignant pleural effusion quickly.

How Is the Trial Designed?

Group I: Observational (pleuroscopy, medical chart review) Experimental Treatment 3 Interventions

Patients undergo biopsy of the lining of the lung using pleuroscopy. Medical chart of patients is also reviewed.

Thoracoscopy is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in European Union as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema
• Thoracic sympathectomy

Approved in Canada as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Approved in Japan as Thoracoscopy for:

• Pulmonary metastases
• Lung cancer
• Pleural effusion
• Pneumothorax
• Empyema

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4058716/

Long-term outcomes after video-assisted thoracic surgery ... Surgical resection of lung cancer in patients without metastasis to other organs may provide a long-term survival benefit compared with nonsurgical therapies.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11393871/

Advancements in Video-Assisted Thoracoscopic Surgery and ... This review summarizes of the advancements in minimally invasive thoracic surgery and the positive impact on patient outcomes.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2666273624000949

Outcomes of single- versus multi-port video-assisted ... We analyzed data collected from the video-assisted thoracoscopic surgery group of a randomized controlled trial to compare differences in pain up to 1 year.

4. cts.springeropen.com cts.springeropen.com/articles/10.1186/s43057-025-00153-5

Comparing perioperative outcomes in video-assisted thoracic ... This study seeks to evaluate the perioperative outcomes of video-assisted thoracic surgery and robotic-assisted thoracic surgery in lung cancer ...

5. vats.amegroups.org vats.amegroups.org/article/view/10623/html

Examining long-term outcomes after robotic versus video ... These studies are small in size and generally show a trend towards improved outcomes for RATS, although this benefit is less marked compared to retrospective ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4153931/

Safety and feasibility of video-assisted thoracoscopic surgery ... This study was regarded as successful if the surgical success rate reached 90% or higher. Results. A total of 51 patients with non-small cell lung cancer (NSCLC) ...

7. iaslc.org iaslc.org/iaslc-news/press-release/video-assisted-thoracoscopy-surgery-reduces-mortality-21-percent-compared

Video Assisted Thoracoscopy Surgery Reduces Mortality ... Video Assisted Thoracoscopy Surgery Reduces Mortality by 21 Percent Compared to Lobectomy ... Video-assisted thoracoscopic surgery (VATS) is ...

8. oncology-central.com oncology-central.com/video-assisted-thoracoscopic-surgery-improves-lung-cancer-survival-rate/

Video–assisted thoracoscopic surgery improves lung ... A new meta–analysis shows video-assisted thoracoscopic surgery (VATS) reduces the risk of death by 21% for patients with lung cancer, ...