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HD+ I-scan Bronchoscopy Vascular Abnormalities Detection Multicenter Study

NCT02285426 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2018-04-12

No results posted yet for this study

Summary

Videobronchoscopy is an essential diagnostic procedure for evaluation of the central airways and pivotal for the diagnosis and staging of lung cancer. Further technological improvements have resulted in high definition (HD+) images and advanced image enhancement technique (i-scan). An earlier study (NCT01676012) has indicated that HD+ bronchoscopy in combination with i-scan technology is superior to HD+WL (white light) for detecting endobronchial vascular changes. In this study we aim to correlate these vascular changes to histology and hypothesize that these vascular changes are related to (pre-) malignant changes and that the addition of i-scan is superior to HD+ WL.

Conditions

  • Lungcancer

Interventions

DEVICE

Pentax EB-1990i HD-bronchoscope guided biopsy

3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree. When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality \[visual scale adapted from Herth 2009 and Zaric 2013\] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control.

Sponsors & Collaborators

  • Radboud University Medical Center

    lead OTHER

Principal Investigators

  • Erik HF van der Heijden, MD, PhD · Principal Investigator

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-20
Primary Completion
2017-06-05
Completion
2017-06-05

Countries

  • Italy
  • Netherlands
  • Russia
  • Spain

Study Locations

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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 NCT02285426 on ClinicalTrials.gov