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

70 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a single-centre, Phase II, prospective study designed to assess BALF and TA-derived biomarkers in relation to metastatic burden in STS patients. BALF and TA samples will be collected during routine bronchoscopy performed as part of standard care at Toronto General Hospital (TGH). Additionally, tissue samples of lung metastases and adjacent normal lung will be collected and used to correlate the identified biomarkers.

Will I have to stop taking my current medications?

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

What data supports the effectiveness of the treatment Bronchoscopy, Metastasectomy for cancer?

Metastasectomy, which involves surgically removing cancer that has spread to the lungs, can be the only curative option for some patients and may improve survival if the cancer is completely removed. Bronchoscopy, a procedure to look inside the lungs, is valuable for diagnosing lung metastases, especially in certain types of cancer like colorectal and breast cancer. ^{1 2 3 4 5}

Is bronchoscopy generally safe for humans?

Bronchoscopy is generally considered a safe procedure, but complications can occur, such as pneumothorax (collapsed lung), bleeding, and in rare cases, death. Safety data from various studies suggest that while it is safe for many patients, certain conditions or trainee involvement may increase the risk of complications. ^{6 7 8 9 10}

How is bronchoscopy used in cancer treatment different from other treatments?

Bronchoscopy is a unique treatment for cancer as it is a minimally invasive procedure that allows doctors to directly view the airways and collect samples for diagnosis, particularly useful for detecting lung metastases. Unlike other treatments that may rely on imaging or systemic therapies, bronchoscopy provides direct access to the lung tissue, making it valuable for diagnosing and managing metastatic lung tumors. ^{3 4 11 12 13}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Romania pubmed.ncbi.nlm.nih.gov

Pulmonary metastasectomy--general issues. [2015]

2. England pubmed.ncbi.nlm.nih.gov

Transdiaphragmatic single-port video-assisted thoracoscopic surgery; a novel approach for pulmonary metastasectomy through laparotomy incision - case series. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Sensitivity, specificity, and predictive values of bronchoscopy in neoplasm metastatic to lung. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Diagnostic Value of Bronchoscopy for Peripheral Metastatic Lung Tumors. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Surgical management of pulmonary metastases. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Increasing Numbers and Reported Adverse Events in Patients with Lung Cancer Undergoing Inpatient Lung Biopsies: A Population-Based Analysis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of flexible bronchoscopy, rigid bronchoscopy, and endobronchial ultrasound-guided transbronchial needle aspiration in patients with malignant space-occupying brain lesions. [2019]

8. England pubmed.ncbi.nlm.nih.gov

Safety of bronchoscopy in patients with malignant hematologic disorders. [2020]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Thirty-Day Complications, Unplanned Hospital Encounters, and Mortality after Endosonography and/or Guided Bronchoscopy: A Prospective Study. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Trainee impact on procedural complications: an analysis of 967 consecutive flexible bronchoscopy procedures in an interventional pulmonology practice. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Flexible fiberoptic bronchoscopy in metastatic cancer to the lungs. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Highly sensitive detection of driver mutations from cytological samples and cfDNA in lung cancer. [2022]

13. Spain pubmed.ncbi.nlm.nih.gov

[Pulmonary metastases of malignant melanoma. A rare endobronchial presentation]. [2018]