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nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

NCT04441749 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2023-02-08

No results posted yet for this study

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

Interventions

DEVICE

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

Sponsors & Collaborators

  • Mauna Kea Technologies

    collaborator INDUSTRY

  • Johnson & Johnson

    collaborator INDUSTRY

  • Fox Chase Cancer Center

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-29
Primary Completion
2021-09-20
Completion
2023-12-31
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04441749 on ClinicalTrials.gov