Bronchoscopy for Cancer

Overseen By David Shultz

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University Health Network, Toronto

Disqualifiers: Other invasive malignancy, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the relationship between certain body markers and cancer spread in individuals with soft tissue sarcoma, a type of cancer. It involves collecting samples during a routine bronchoscopy (a procedure to examine the lungs) and metastasectomy (surgery to remove lung tumors). Researchers aim to gain a deeper understanding of cancer behavior by analyzing these samples. Individuals with soft tissue sarcoma undergoing surgery to remove lung lesions may be suitable candidates for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing valuable insights into its efficacy.

Will I have to stop taking my current medications?

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

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that bronchoscopy, a procedure using a thin, flexible tube to examine the lungs, is generally safe. One study found that only about 3.8% of participants experienced issues, mostly minor, such as a small lung puncture or slight bleeding. Importantly, no participants had serious breathing problems.

Metastasectomy, the surgery to remove cancer that has spread to the lungs, is often part of standard care, indicating it is well-understood and generally safe. Since this trial is in phase 2, earlier phases have already provided some safety data. This suggests that both procedures are relatively well-tolerated, making them a promising option for patients considering joining the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it combines bronchoscopy with metastasectomy to potentially enhance cancer treatment. Unlike standard treatments that may focus solely on surgical removal or chemotherapy, this approach collects bronchoalveolar lavage fluid (BALF) and tissue samples during routine procedures. This allows for a more comprehensive understanding of lung cancer at a cellular level, which could lead to more targeted and effective treatments. The integration of sample collection with standard care procedures is innovative, offering insights without additional invasive techniques. This trial aims to uncover how these combined methods can improve cancer treatment outcomes.

What evidence suggests that this trial's treatments could be effective for cancer?

Studies have shown that bronchoscopy effectively diagnoses lung metastases, which is cancer that has spread to the lungs. For example, a large study involving 235 cases found that bronchoscopy correctly identified the disease about 76.6% of the time, successfully detecting lung cancer in most cases. Another study demonstrated that bronchoscopy was particularly effective for patients whose lung cancer spread from colorectal cancer, achieving a success rate of 79%. In this trial, participants will undergo routine bronchoscopy alongside standard of care metastasectomy. These findings suggest that bronchoscopy can reliably detect the spread of lung cancer, aiding in further treatment decisions. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for patients with sarcoma, a type of cancer that may spread to the lungs. Participants must be undergoing routine bronchoscopy at Toronto General Hospital as part of their standard care and can provide tissue samples from lung metastases.

Inclusion Criteria

Ability to understand and willingness to sign a written informed consent document

I have been diagnosed with soft tissue sarcoma.

I am scheduled for lung surgery as part of my treatment.

Exclusion Criteria

I had cancer before, but it was either skin cancer or another type cured over 2 years ago with no current signs.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Sample Collection

BALF and TA samples are collected during routine bronchoscopy and standard of care metastasectomy

2 years

Visits as per standard care schedule

Analysis

Comprehensive multi-omic analysis of collected specimens to characterize molecular landscape and identify biomarkers

2 years

Follow-up

Participants are monitored for safety and effectiveness after sample collection and analysis

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bronchoscopy
• Metastasectomy

Trial Overview

The study aims to identify biomarkers in Bronchoalveolar Lavage Fluid (BALF) and Tissue Aspirate (TA) that correlate with the extent of lung metastasis in Soft Tissue Sarcoma (STS) patients using bronchoscopy and metastasectomy procedures.

How Is the Trial Designed?

Group I: Routine Bronchoscopy & SOC Metastasectomy Experimental Treatment 1 Intervention

BALF and TA will be collected during routine bronchoscopy, and resected lung metastases and adjacent normal tissue will be collected during standard of care metastasectomy

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

A study analyzing data from 540,747 lung cancer patients revealed that the incidence of adverse events during lung biopsies increased significantly from 24% in 2001 to 38% in 2010, indicating a growing concern for patient safety.

Patients who experienced adverse events had longer hospital stays and a significantly higher risk of in-hospital mortality, with an adjusted odds ratio of 5.9, highlighting the need for improved safety measures in lung biopsy procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. von Itzstein, MS., Gupta, A., Mara, KC., et al.[2020]

In a 15-month study of 697 patients undergoing advanced diagnostic bronchoscopy, severe complications were rare, occurring in only 2.4% of patients, but they had serious consequences, including unplanned hospital visits and deaths.

Many complications occurred days or weeks after the procedure, highlighting the need for proactive monitoring to identify and manage these delayed adverse events effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Thirty-Day Complications, Unplanned Hospital Encounters, and Mortality after Endosonography and/or Guided Bronchoscopy: A Prospective Study. Magnini, D., Sotgiu, G., Bello, G., et al.[2023]

In a study of 1,100 interventional pulmonology procedures, trainee involvement was linked to longer procedure times (average of 50.81 minutes compared to 32.49 minutes) and increased sedation requirements, indicating a potential impact on efficiency.

The presence of trainees also correlated with a higher complication rate (4.5% with trainees vs. 1.2% without), suggesting that while training is essential, it may pose additional risks to patients during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Trainee impact on procedural complications: an analysis of 967 consecutive flexible bronchoscopy procedures in an interventional pulmonology practice. Stather, DR., MacEachern, P., Chee, A., et al.[2022]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8773960/

Diagnostic Value of Bronchoscopy for Peripheral Metastatic ...

We analyzed 235 lesions consecutively, and the overall diagnostic yield was 76.6%, which was slightly higher than the reported cumulative ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0012369216514202

Sensitivity, Specificity, and Predictive Values of ...

Bronchoscopy for metastatic lung disease was most likely diagnostic in patients with primary colorectal cancer (79 percent) and breast cancer (57 percent).

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12172655/

Robotic-assisted bronchoscopy—advancing lung cancer ...

The preliminary results were reported in 2022, showing a stable performance was achieved after 18 cases of biopsy, in which the total procedural ...

4.

mdpi.com

mdpi.com/2072-6694/14/2/375/review_report

Diagnostic Value of Bronchoscopy for Peripheral ...

Among the 93 patients who underwent surgery in this study, 55 were diagnosed with metastatic lung tumors by bronchoscopic biopsy in advance. As described in ...

5.

jtd.amegroups.org

jtd.amegroups.org/article/view/36668/html

Evaluating the efficacy of bronchoscopy for the diagnosis of ...

Novel diagnostic techniques for lung cancer are rapidly evolving. Specifically, several novel changes to bronchoscopy are reaching clinical evaluation.

6.

sciencedirect.com

sciencedirect.com/science/article/pii/S0012369225005483

A Prospective, Multicenter Evaluation of Safety and ...

Results: The adjudicated primary safety end point was observed in 3.8% of participants (19 pneumothorax, 7 bleeding, and 0 respiratory failure).

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11348910/

Interventional bronchoscopy in lung cancer treatment - PMC

Important clinical outcomes in bronchoscopic treatment of CAO include technical success, weaning from mechanical ventilation, dyspnoea, health- ...

8.

jto.org

jto.org/article/S1556-0864(25)00722-1/fulltext

Safety and Sample Adequacy for Comprehensive ...

Assessing the early returns of robotic-assisted bronchoscopy in a patient population at high risk for cancer: factors associated with a diagnostic procedure ...

9.

atsjournals.org

atsjournals.org/doi/full/10.1513/AnnalsATS.202311-943RL

Outcomes of Therapeutic Bronchoscopy in Malignant ...

To the Editor: Therapeutic bronchoscopy has showed success on multiple clinical outcomes and sufficient safety in malignant central airway obstruction ...

10.

jtd.amegroups.org

jtd.amegroups.org/article/view/7443/html

Safety and feasibility of prolonged bronchoscopy involving ...

Results: Twenty-one patients met our criteria, one having 2 synchronous tumors. 95% of patients had an ASA score of at least 3. Twenty-two tumors were diagnosed ...