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nCLE For Diagnosis Of Peripheral Lung Nodules By Robotic Navigational Bronchoscopy

NCT04441749 · Fox Chase Cancer Center · Updated 8 Feb 2023

What is being tested
Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)
For
Diagnosis of Peripheral Lung Nodules
Kind of study
Watches patients without assigning a treatment. No drug phase (a device or procedure study).
Who can join
Ages 18 years and older. About 25 people. The full rules are on the registry page.
Where
United States, Netherlands (2 sites)
When
Starts or started 29 June 2020, ends Dec 2023. Registered 22 June 2020.
Results
None posted yet.

In the researchers' words

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.
ClinicalTrials.gov, NCT04441749

Sites

  • Fox Chase Cancer CenterPhiladelphia, Pennsylvania, United States
  • Amsterdam University Medical CenterAmsterdam, AZ, Netherlands