What side effects are associated with this type of intervention?

Common treatments for lung cancer, including chemotherapy, immunotherapy, and targeted therapies, have a range of side effects. Chemotherapy can cause nausea, vomiting, hair loss, fatigue, and increased risk of infection. Immunotherapy, such as pembrolizumab and atezolizumab, may lead to immune-related side effects like rash, diarrhea, and inflammation of organs (e.g., pneumonitis, colitis). Targeted therapies can cause skin problems, diarrhea, and liver issues. Diagnostic procedures like Needle-based Confocal Laser Endomicroscopy (nCLE) are generally safe but may involve risks such as bleeding, infection, and discomfort at the biopsy site.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of lung cancer, particularly focusing on advanced non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC). Notable approvals include immune checkpoint inhibitors such as pembrolizumab (Keytruda) and atezolizumab (Tecentriq), which have shown efficacy in combination with chemotherapy. Additionally, targeted therapies like osimertinib (Tagrisso) for EGFR mutations and alectinib (Alecensa) for ALK mutations have been approved. While the context does not provide specific FDA approvals related to needle-based confocal laser endomicroscopy (nCLE), these advanced imaging techniques are being studied to improve diagnostic accuracy and treatment outcomes in lung cancer.

What other types of research exist?

Promising alternatives to nCLE for lung cancer patients include Next-Generation Sequencing (NGS)-based biomarker testing, which has seen increased adoption and provides comprehensive genomic profiling. Additionally, integrated PET/CT scans offer high sensitivity for detecting metastases and can be combined with intravenous contrast for enhanced imaging. Robotic-assisted bronchoscopy (RANB) with advanced imaging techniques also shows potential for improved diagnostic accuracy.

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Imaging

nCLE Aided Robotic Bronchoscopy for Lung Cancer (CLEAR Trial)

N/A

Waitlist Available

Research Sponsored by Johnson & Johnson Enterprise Innovation Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 22 years at signing of informed consent form (ICF)

Be older than 18 years old

Must not have

Planned surgical resection at the time of bronchoscopy

Female subjects who are pregnant or nursing at the time of the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 12 months post procedure

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new method that uses a tiny camera on a needle to take detailed pictures of lung tissue. It aims to help doctors accurately diagnose small growths in the lungs by providing live images of the tissue. This could improve the precision of lung biopsies and reduce the need for additional imaging tools.

Who is the study for?

This trial is for adults over 22 years old who need a lung nodule biopsy and are fit enough for bronchoscopy under anesthesia. They must not have bleeding disorders, be on certain blood thinners, or have devices like pacemakers that could interfere with the procedure. Pregnant or nursing women and those with known allergies to fluorescein sodium can't participate.

What is being tested?

The study tests if using needle-based confocal laser endomicroscopy (nCLE) can make biopsies of lung nodules more accurate when done with robotic-assisted bronchoscopy (RANB) using the Monarch® Endoscopy Platform.

What are the potential side effects?

Potential side effects may include discomfort from the biopsy procedure, risks associated with general anesthesia, allergic reactions to fluorescein sodium used in nCLE, and possible complications from bronchoscopy such as bleeding or infection.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 22 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am scheduled for surgery to remove part of my lung during a bronchoscopy.

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I am currently pregnant or nursing.

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My chest CT shows a lesion affecting my airways.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 12 months post procedure

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 12 months post procedure

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 12 months post procedure for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

'Tool-in-lesion' positioning accuracy of nCLE during RANB biopsy.

Secondary study objectives

Diagnostic yield

Intra- and inter-observer agreement of the post-procedure nCLE imaging for malignancy

Safety of nCLE aided RANB biopsy procedure

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: nCLE aided RANB biopsyExperimental Treatment1 Intervention

Single arm study

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for lung cancer include chemotherapy, targeted therapy, immunotherapy, and radiation therapy. Chemotherapy works by killing rapidly dividing cancer cells, but it can also affect normal cells, leading to side effects. Targeted therapy, such as EGFR inhibitors like afatinib, specifically targets cancer cell mutations, offering a more personalized treatment with potentially fewer side effects. Immunotherapy, including PD-1/PD-L1 inhibitors, boosts the body's immune system to recognize and attack cancer cells. Radiation therapy uses high-energy rays to destroy cancer cells and shrink tumors. The relevance of these treatments lies in their ability to improve survival rates and quality of life for lung cancer patients. The nCLE trial's focus on real-time, high-resolution cellular imaging aims to enhance diagnostic accuracy, potentially leading to more precise and effective treatment plans.

Large Cell Neuro-Endocrine Carcinoma of the Lung: Current Treatment Options and Potential Future Opportunities.Small or Non-Small Cell Lung Cancer Based Therapy for Treatment of Large Cell Neuroendocrine Cancer of The Lung? University of Cincinnati Experience.A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.