The online version of this article (doi:10.1186/s12890-017-0403-9) contains supplementary material, which is available to authorized users.
Prior Presentation: Presented at the IASLC 17th World Conference on Lung Cancer, December 5, 2016: Folch E, Flandes J, Khandhar S. MA05.02 Electromagnetic Navigation Bronchoscopy: A Prospective, Global, Multicenter Analysis of 1000 Subjects with Lung Lesions. Journal of Thoracic Oncology. 2017;12:S365.
Electromagnetic navigation bronchoscopy (ENB) is an image-guided, minimally invasive approach that uses a flexible catheter to access pulmonary lesions.
NAVIGATE is a prospective, multicenter study of the superDimension™ navigation system. A prespecified 1-month interim analysis of the first 1,000 primary cohort subjects enrolled at 29 sites in the United States and Europe is described. Enrollment and 24-month follow-up are ongoing.
ENB index procedures were conducted for lung lesion biopsy (n = 964), fiducial marker placement (n = 210), pleural dye marking (n = 17), and/or lymph node biopsy (n = 334; primarily endobronchial ultrasound-guided). Lesions were in the peripheral/middle lung thirds in 92.7%, 49.7% were <20 mm, and 48.4% had a bronchus sign. Radial EBUS was used in 54.3% (543/1,000 subjects) and general anesthesia in 79.7% (797/1,000). Among the 964 subjects (1,129 lesions) undergoing lung lesion biopsy, navigation was completed and tissue was obtained in 94.4% (910/964). Based on final pathology results, ENB-aided samples were read as malignant in 417/910 (45.8%) subjects and non-malignant in 372/910 (40.9%) subjects. An additional 121/910 (13.3%) were read as inconclusive. One-month follow-up in this interim analysis is not sufficient to calculate the true negative rate or diagnostic yield. Tissue adequacy for genetic testing was 80.0% (56 of 70 lesions sent for testing). The ENB-related pneumothorax rate was 4.9% (49/1,000) overall and 3.2% (32/1,000) CTCAE Grade ≥2 (primary endpoint). The ENB-related Grade ≥2 bronchopulmonary hemorrhage and Grade ≥4 respiratory failure rates were 1.0 and 0.6%, respectively.
One-month results of the first 1,000 subjects enrolled demonstrate low adverse event rates in a generalizable population across diverse practice settings. Continued enrollment and follow-up are required to calculate the true negative rate and delineate the patient, lesion, and procedural factors contributing to diagnostic yield.
ClinicalTrials.gov NCT02410837. Registered 31 March 2015.
Additional file 1: Study assessments. (DOCX 52 kb)12890_2017_403_MOESM1_ESM.docx
Additional file 2: Study definitions. (DOCX 56 kb)12890_2017_403_MOESM2_ESM.docx
Additional file 3: Study sites enrolling subjects in the 1,000-Patient interim analysis. (DOCX 53 kb)12890_2017_403_MOESM3_ESM.docx
Additional file 4: Ethics committee approvals. (DOCX 54 kb)12890_2017_403_MOESM4_ESM.docx
National Cancer Institute, Cancer Therapy Evaluation Program, United States Department of Health and Human Services, National Institutes of Health. Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0. http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm#ctc_40. Accessed 16 Dec 2016.
Centers for Medicare & Medicaid Services, United States Department of Health and Human Services. Decision Memo for Screening for Lung Cancer with Low Dose Computed Tomography (LDCT) (CAG-00439 N, 5 Feb 2015). https://www.cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274. Accessed 16 Dec 2016.
Gould MK, Donington J, Lynch WR, Mazzone PJ, Midthun DE, Naidich DP, et al. Evaluation of individuals with pulmonary nodules: when is it lung cancer? Diagnosis and management of lung cancer, 3rd ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest. 2013;143:e93S–120. CrossRefPubMedPubMedCentral
Garwood SK, ClenDening P, Hevelone ND, Hood KL, Pidgeon S, Wudel LJ. Navigational bronchoscopy at a community hospital: clinical and economic outcomes. Lung Cancer Manag. 2016;5:131–40. CrossRef
- Electromagnetic navigation bronchoscopy to access lung lesions in 1,000 subjects: first results of the prospective, multicenter NAVIGATE study
Sandeep J. Khandhar
Mark R. Bowling
Thomas R. Gildea
Kristin L. Hood
William S. Krimsky
Douglas J. Minnich
Septimiu D. Murgu
Eric M. Toloza
Momen M. Wahidi
Jennifer J. Wolvers
Erik E. Folch
for the NAVIGATE Study Investigators
- BioMed Central
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