nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

NCT ID: NCT04441749

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-06-29
• Study Completion Date: 2023-12-31

Brief Summary

Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis. (Wijmans, et al., 2019). The effectiveness of nCLE with intravenous fluorescein has been demonstrated in central lung cancers using esophageal ultrasound guided needle placement (Wijmans, et al., 2019). In this study, the proposed nCLE lung cancer criteria had high accuracy for lung cancer detection and were consistently recognized by multiple raters. Probe based confocal microscopy (pCLE) has also been used in conjunction with a radial probe EBUS in evaluating solitary pulmonary nodules with a diagnostic accuracy of 79.2%. (Hassan, et al., 2017) Needle based confocal laser endomicroscopy (nCLE) has not previously been used in conjunction with robotic navigational bronchoscopy.

Conditions

Diagnosis of Peripheral Lung Nodules

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

nCLE Analysis

Needle based confocal laser endomicroscopy (nCLE) employs a small fiber which can be passed through a biopsy needle to enable real time microscopic imaging of cells. With resolution of 3.5 microns it is possible to identify key features consistent with malignancy and pulmonary fibrosis

Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)

Intervention Type: DEVICE

Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed

Interventions

Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)

Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Men and women, regardless of race, ethnic group or sexual orientation are eligible for this study.
• Patients undergoing robotic navigational bronchoscopy for evaluation of indeterminate lung nodules with largest dimension size of 8-30 mm
• Age > 18 years.
• Patients must have normal organ and marrow functions as defined below:

Leukocytes > 3,000/mcL Absolute neutrophil count > 1,500/mcL Total bilirubin within normal institutional limits Hemoglobin ≥7.0 AST/ALT (SGOT/SGPT) < 2 times institutional normal limits Creatinine OR Creatinine Clearance within normal institutional limits OR > 60 Ml/min/1.73 m2 for patients with creatinine levels above institutional normal

• Ability to understand and willingness to sign a written informed consent and HIPAA consent document
• WOCBP must agree not to get pregnant until after the day of the procedure

Exclusion Criteria

• Patients with uncorrectable coagulopathy will be excluded.
• Known allergy to fluorescein or other contrast media
• Patients with hemodynamic instability will be excluded
• Patients with refractory hypoxemia will be excluded
• Patients with therapeutic anticoagulant that cannot be held for an appropriate interval prior to the procedure
• Patients who are unable to tolerate general anesthesia according to the anesthesiologist
• Patient requires chemotherapy
• Pregnant or breast feeding. Refer to section 4.5 for further detail.
• Subject has participated in an investigational drug or device research study within 30 days of enrollment that would interfere with this study
• Pregnancy:

Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will be excluded from the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mauna Kea Technologies

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson

INDUSTRY

Sponsor Role: collaborator

Fox Chase Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

Amsterdam University Medical Center

Amsterdam, AZ, Netherlands

Countries

United States; Netherlands

References

Manley CJ, Kramer T, Kumar R, Gong Y, Ehya H, Ross E, Bonta PI, Annema JT. Robotic bronchoscopic needle-based confocal laser endomicroscopy to diagnose peripheral lung nodules. Respirology. 2023 May;28(5):475-483. doi: 10.1111/resp.14438. Epub 2022 Dec 19.

Reference Type: DERIVED

PMID: 36535801 (View on PubMed)

Other Identifiers

TH-168

Identifier Type: OTHER

Identifier Source: secondary_id

20-1006

Identifier Type: -

Identifier Source: org_study_id