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| ID | Type | Description | Link |
|---|---|---|---|
| TH-168 | Other Identifier | Fox Chase cancer Center |
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| Name | Class |
|---|---|
| Mauna Kea Technologies | INDUSTRY |
| Johnson & Johnson | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE) | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Ability to obtain good quality nCLE images of lung nodules | Good quality nCLE images of lung nodules/ surrounding tissue in ≥80% of patients provided the peripheral lung nodule | 1 year |
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Inclusion Criteria:
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
Exclusion Criteria:
Women of child-bearing potential (WOCBP) who are pregnant on the day of the procedure will be excluded from the study.
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Patients will be enrolled from outpatient pulmonary clinic and from direct referrals from the inpatient pulmonary service and thoracic tumor board. Patients who scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion at Fox Chase Fox Center will be contacted to participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States | ||
| Amsterdam University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36535801 | Derived | 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. |
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Tissue lung nodule) acquisition by transbronchial needle aspiration/ biopsy (standard of care)
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| Amsterdam |
| AZ |
| 1105 |
| Netherlands |