Confocal Laser Endomicroscopy for Lung Cancer

Recruiting at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Beta-blockers, Anticoagulants

Disqualifiers: Pregnancy, Hemodynamic instability, Hypoxemia, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Up to 2 years

3 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial compares the addition of needle-based confocal laser endomicroscopy (nCLE) and fluorescein to endobronchial ultrasound-guided transbronchial needle aspiration (EBUS TBNA) with EBUS TBNA alone for the diagnosis of lung cancer in patients with peripheral pulmonary nodules. EBUS TBNA is a diagnostic procedure that can be used to sample lung tissue. nCLE is a novel high-resolution imaging technique that uses a laser light to create real-time microscopic images of tissues. It can be integrated into needles allowing real-time cancer detection during endoscopy. Fluorescein is an imaging agent that can be used to visualize tissue. Using nCLE and fluorescein in combination with EBUS TBNA may be more effective in diagnosing lung cancer than using EBUS TBNA alone.

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

The trial protocol does not specify if you need to stop taking all current medications. However, you must not use beta-blockers within 24 hours before the procedure, and therapeutic anticoagulants must be held for an appropriate interval before the procedure. If you are undergoing chemotherapy, you cannot participate in the trial.

Will I have to stop taking my current medications?

The trial requires that you stop using beta-blockers 24 hours before the procedure and hold any therapeutic anticoagulants for an appropriate time before the procedure. If you are on these medications, you may need to stop them temporarily.

What data supports the idea that Confocal Laser Endomicroscopy for Lung Cancer is an effective treatment?

The available research shows that Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA), which is related to Confocal Laser Endomicroscopy, is a standard and important tool for diagnosing and staging lung cancer. It is considered safe and effective for examining lung tissues and has been used successfully with different needle sizes to obtain tumor samples. This suggests that similar techniques, like Confocal Laser Endomicroscopy, could also be effective in treating lung cancer. ^{1 2 3 4 5}

What data supports the effectiveness of the treatment Needle-Based Confocal Laser Endomicroscopy with Fluorescein for lung cancer?

The research highlights that Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA) is a standard and effective procedure for diagnosing and staging lung cancer, which suggests that combining it with Needle-Based Confocal Laser Endomicroscopy could enhance its diagnostic capabilities. ^{1 2 3 4 5}

Is endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) generally safe for humans?

EBUS-TBNA is generally considered safe, but there are rare reports of complications, including infections. Studies have focused on understanding these risks to improve patient safety. ^{6 7 8 9 10}

What safety data is available for Confocal Laser Endomicroscopy in lung cancer treatment?

The safety data for Confocal Laser Endomicroscopy, particularly when used in conjunction with procedures like EBUS-TBNA, indicates that complications are rare. Several studies have focused on the incidence and risk factors of infectious complications associated with EBUS-TBNA, suggesting that while the procedure is generally safe, there are some risks involved. These studies highlight the importance of understanding potential complications, such as acute mediastinitis and other infectious issues, to ensure patient safety during and after the procedure. ^{6 7 8 9 10}

Is the treatment EBUS-TBNA promising for lung cancer?

Yes, EBUS-TBNA is a promising treatment for lung cancer because it is a new, minimally invasive method that helps doctors diagnose and stage lung cancer effectively. It is safe, simple, and fast, with a good cost/benefit ratio compared to older methods. ^{2 3 11 12 13}

What makes the treatment EBUS-TBNA unique for lung cancer?

EBUS-TBNA (Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration) is unique because it is a minimally invasive procedure that allows doctors to obtain tissue samples for diagnosing and staging lung cancer, offering a safer and faster alternative with a better cost/benefit ratio compared to traditional methods. ^{2 3 11 12 13}

Research Team

Sebastian Fernandez-Bussy, M.D.

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for adults over 21 who suspect they have lung cancer with nodules sized between 8-30mm on a CT scan. They must understand and sign consent forms, not be pregnant or breastfeeding, and can't have used beta-blockers or certain anticoagulants recently. Those allergic to fluorescein or unable to tolerate general anesthesia are excluded.

Inclusion Criteria

I am 21 years old or older.

Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document

Possible peripheral polyneuropathy.

Exclusion Criteria

My lung lesions could not be found or confirmed during surgery.

You are allergic to fluorescein or have a high chance of having an allergic reaction.

You cannot handle the type of anesthesia used for surgery, according to the doctor who gives the anesthesia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients undergo robotic EBUS TBNA, with some receiving nCLE and fluorescein IV

Up to 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including adverse events and diagnostic performance

12 months

Treatment Details

Interventions

• Fluorescein
• Needle-Based Confocal Laser Endomicroscopy
• Ultrasound-Guided Transbronchial Needle Aspiration

Trial Overview The study tests if using needle-based confocal laser endomicroscopy (nCLE) with an imaging agent called fluorescein alongside standard EBUS TBNA improves lung cancer diagnosis in patients with peripheral pulmonary nodules compared to just EBUS TBNA.

Participant Groups

Group I: Arm II (EBUS TBNA, nCLE, fluorescein) Experimental Treatment 3 Interventions

Patients undergo EBUS TBNA, nCLE, and receive fluorescein IV on study.

Group II: Arm I (EBUS TBNA) Active Control 1 Intervention

Patients undergo robotic EBUS TBNA on study.

Ultrasound-Guided Transbronchial Needle Aspiration is already approved in European Union, United States, Canada, Japan for the following indications:

Approved in European Union as EBUS-TBNA for:

• Diagnosis and staging of lung cancer
• Evaluation of mediastinal lymph nodes

Approved in United States as EBUS-TBNA for:

• Diagnosis and staging of lung cancer
• Evaluation of mediastinal lymph nodes
• Detection of infections and inflammatory diseases

Approved in Canada as EBUS-TBNA for:

• Diagnosis and staging of lung cancer
• Evaluation of mediastinal lymph nodes

Approved in Japan as EBUS-TBNA for:

• Diagnosis and staging of lung cancer
• Evaluation of mediastinal lymph nodes

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Findings from Research

Using a 19-G needle for EBUS-TBNA in 50 patients with suspected metastatic lung cancer resulted in a high success rate for testing molecular markers, with 90% success for PD-L1 and EGFR, and 86% for ALK, indicating its efficacy in obtaining sufficient tumor tissue.

The procedure was safe, with no adverse events reported, demonstrating that the larger needle size does not compromise patient safety while improving the quality and quantity of tissue samples for cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of the Performance of 19-G Needle in Endobronchial Ultrasound-guided Transbronchial Aspiration for the Diagnosis and Testing of Molecular Markers in Lung Cancer. Wahidi, MM., Davidson, K., Shofer, S., et al.[2023]

Endobronchial ultrasound-guided transbronchial aspiration (EBUS-TBNA) demonstrated high diagnostic accuracy in non-small cell lung cancer (NSCLC) patients, with an overall sensitivity of 92.3% and specificity of 100% across 164 patients studied from 2007 to 2009.

The use of EBUS-TBNA not only effectively diagnosed and staged NSCLC but also allowed 54.7% of patients with confirmed malignancy to avoid unnecessary surgery, highlighting its role as a less invasive initial diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Roles of EBUS-TBNA in non-small cell lung cancer. Chung, FT., Kuo, CH., Chen, HC., et al.[2019]

Both computer EBUS-TBNA simulation and wet lab simulation are effective for teaching basic EBUS-TBNA skills, with no significant differences in procedure time or successful biopsy rates between the two methods.

However, the computer simulation group was better at correctly identifying lymph nodes, while wet lab simulation increased learner confidence in using the actual EBUS-TBNA bronchoscope, suggesting that both methods provide valuable but different learning benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wet laboratory versus computer simulation for learning endobronchial ultrasound: a randomized trial. Stather, DR., MacEachern, P., Chee, A., et al.[2022]

In a study of 15 lesions, EBUS-TBNA was successfully performed in 11 cases, demonstrating that the procedure is feasible in bronchi with a mean internal diameter of at least 4.5 mm.

No complications were reported during the procedure, indicating that EBUS-TBNA is a safe method for diagnosing lesions adjacent to narrow bronchi.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The usefulness of endobronchial ultrasonography-guided transbronchial needle aspiration at the lobar, segmental, or subsegmental bronchus smaller than a convex-type bronchoscope. Kurimoto, N., Inoue, T., Miyazawa, T., et al.[2022]

A total of 711 EBUS-TBNA procedures were analyzed, showing an increase in diagnostic quality from an initial 60.9% to 82.4% over the study period, highlighting the importance of continuous practice and evaluation in improving skills.

The introduction of rapid on-site cytological evaluation (ROSE) significantly enhanced the proportion of representative EBUS-TBNA results, with a high sensitivity of 94.9% for detecting malignancy, indicating its effectiveness as a diagnostic tool for lung cancer and mediastinal lymphadenopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Learning endobronchial ultrasound transbronchial needle aspiration - a 6-year experience at a single institution. Sørhaug, S., Hjelde, H., Hatlen, P., et al.[2018]

In a study of 1,317 patients undergoing EBUS-TBNA, complications occurred in only 1.44% of cases, indicating that the procedure is generally safe.

Transbronchial lung biopsy (TBBx) was identified as a significant risk factor for complications, with a higher incidence of complications in patients who underwent TBBx compared to those who did not. Additionally, the use of rapid on-site cytologic evaluation (ROSE) was associated with a reduced need for TBBx.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complications, consequences, and practice patterns of endobronchial ultrasound-guided transbronchial needle aspiration: Results of the AQuIRE registry. Eapen, GA., Shah, AM., Lei, X., et al.[2022]

A 67-year-old man developed acute mediastinitis 13 days after undergoing EBUS-TBNA to diagnose an enlarged mediastinal lymph node, highlighting a rare but serious complication of the procedure.

Prompt treatment with antibiotics led to significant improvement in his symptoms and laboratory markers, emphasizing the importance of monitoring for complications after EBUS-TBNA, especially in cases involving necrotic lymph nodes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. Kurimoto, N., Shinmyo, T., Tagay, R., et al.[2013]

In a study of 6826 patients undergoing EBUS-TBNA, only 33 (0.48%) experienced infectious complications, primarily pneumonia and mediastinal infections, indicating that such complications are rare.

Risk factors for these infections included the presence of necrotic features in target lesions on CT scans and procedures performed via the esophagus, suggesting that careful evaluation of these factors is important for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infectious complications of EBUS-TBNA: A nested case-control study using 10-year registry data. Kang, N., Shin, SH., Yoo, H., et al.[2021]

In a study of 370 patients undergoing EBUS-TBNA, the overall incidence of infectious complications was low at 4.05%, with a significantly higher rate (5.7%) in patients with risk factors compared to 0.8% in those without risk factors.

The study identified necrotic lesions as a specific risk factor for post-EBUS infections, suggesting that procedures involving these lesions should be approached with caution, although no fatalities occurred, indicating that EBUS-TBNA is generally a safe procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Infectious Complications of EBUS-TBNA: Prospective Multicenter Study. Serra Mitjà, P., Gonçalves Dos Santos Carvalho, F., Garcia Olivé, I., et al.[2023]

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a safe and effective procedure for diagnosing mediastinal and hilar lymphadenopathy, with a diagnostic yield of 79% across both malignant and benign conditions based on a study of 52 patients.

The procedure demonstrated high sensitivity (78.6%) and specificity (100%) for identifying lymph node abnormalities, making it a valuable tool for staging malignancies and diagnosing conditions like tuberculosis and sarcoidosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility and safety of endobronchial ultrasound-guided transbronchial needle aspiration in patients with mediastinal and hilar lymphadenopathy: Western region experience. Aljohaney, AA.[2020]

Endobronchial ultrasound (EBUS) is a new, minimally invasive technique that allows pulmonologists to diagnose and stage lung cancer effectively by obtaining tissue samples through transbronchial needle aspiration (EBUS-TBNA).

This method is not only safe and simple but also offers a superior cost/benefit ratio compared to traditional diagnostic methods, making it an attractive option for lung cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound EBUS--a new method for the diagnosis and staging of lung cancer. Simon, M., Baldea, L., Pop, B., et al.[2015]

In a study analyzing 5279 bronchoscopies, lung cancer (LC) was confirmed in 36.42% of patients, highlighting the effectiveness of bronchoscopy in diagnosing respiratory diseases.

The study found that different biopsy techniques have varying success rates: squamous cell lung cancer was diagnosed more frequently with endobronchial forceps biopsy, while adenocarcinoma and non-small cell lung cancer were more effectively diagnosed using EBUS-TBNA and EUS-FNA, indicating that the choice of technique should depend on the cancer type and location.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Observational cross-sectional study of 5279 bronchoscopy results for the practical effectiveness of various biopsy techniques in the diagnosis of lung diseases with particular emphasis on lung cancer. Błach, J., Frąk, M., Krawczyk, P., et al.[2022]

In a study of 39 patients suspected of having lymphoma, the 19-gauge EBUS-TBNA needle demonstrated a sensitivity of 83% for detecting lymphoma, indicating it is an effective tool for diagnosis.

The overall sensitivity for definitive diagnosis of lymphoma using the 19G needle was 65%, which is comparable to the standard 22-gauge needle, but some patients still required further invasive procedures for accurate subtype characterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 19-gauge endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in suspected lymphoma: A prospective cohort study. Lim, CE., Steinfort, DP., Irving, LB.[2021]

References

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

Pilot Study of the Performance of 19-G Needle in Endobronchial Ultrasound-guided Transbronchial Aspiration for the Diagnosis and Testing of Molecular Markers in Lung Cancer. [2023]

2. Singapore pubmed.ncbi.nlm.nih.gov

Roles of EBUS-TBNA in non-small cell lung cancer. [2019]

3. Egypt pubmed.ncbi.nlm.nih.gov

Wet laboratory versus computer simulation for learning endobronchial ultrasound: a randomized trial. [2022]

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

The usefulness of endobronchial ultrasonography-guided transbronchial needle aspiration at the lobar, segmental, or subsegmental bronchus smaller than a convex-type bronchoscope. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Learning endobronchial ultrasound transbronchial needle aspiration - a 6-year experience at a single institution. [2018]

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

Complications, consequences, and practice patterns of endobronchial ultrasound-guided transbronchial needle aspiration: Results of the AQuIRE registry. [2022]

7. Japan pubmed.ncbi.nlm.nih.gov

[A case of acute mediastinitis after endobronchial needle aspiration]. [2013]

8. Ireland pubmed.ncbi.nlm.nih.gov

Infectious complications of EBUS-TBNA: A nested case-control study using 10-year registry data. [2021]

9. Spain pubmed.ncbi.nlm.nih.gov

Incidence and Risk Factors for Infectious Complications of EBUS-TBNA: Prospective Multicenter Study. [2023]

10. India pubmed.ncbi.nlm.nih.gov

Utility and safety of endobronchial ultrasound-guided transbronchial needle aspiration in patients with mediastinal and hilar lymphadenopathy: Western region experience. [2020]

11. Romania pubmed.ncbi.nlm.nih.gov

Endobronchial ultrasound EBUS--a new method for the diagnosis and staging of lung cancer. [2015]

12. England pubmed.ncbi.nlm.nih.gov

Observational cross-sectional study of 5279 bronchoscopy results for the practical effectiveness of various biopsy techniques in the diagnosis of lung diseases with particular emphasis on lung cancer. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Diagnostic performance of 19-gauge endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) in suspected lymphoma: A prospective cohort study. [2021]