NCT01178190

Brief Summary

Narrow band imaging (NBI) videobronchoscopy is an optical technique in which filtered light enhances superficial neoplasm based on their neoangiogenic pattern. The objectives of this study investigate its better diagnostic yield in the assessment of lung cancer than conventional flexible bronchoscopy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2010

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 10, 2010

Completed
Last Updated

August 10, 2010

Status Verified

June 1, 2010

Enrollment Period

11 months

First QC Date

July 28, 2010

Last Update Submit

August 9, 2010

Conditions

Lung Cancer

Keywords

narrow band imagingmalignant lesionlung cancerNBI

Outcome Measures

Primary Outcomes (1)

  • accuracy of NBI videobronchoscopic biopsy

    Define and compare the sensitivity, specificity, positive predictive value, negative predictive value, likelihood ratio and accuriacies for the diagnostic techniques for lung cancer.

    10-11 months

Secondary Outcomes (1)

  • early cancer lesion detection rate using Shibuya descriptors

    10-11 months

Study Arms (1)

lung cancer

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

suspected endobroncheal lesion on chest CT

You may qualify if:

  • endobronchial lesion on chest CT

You may not qualify if:

  • Age \< 18 years old
  • Inability to consent for the study
  • Inability to tolerate bronchoscopy
  • Active pulmonary infection (bronchitis, pneumonia)
  • ST elevation or depression on ECG
  • Prothrombin time prolongation(\<70%)
  • platelet \<10,000

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ChangMin, Choi

Seoul, Seoul, South Korea

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • ChangMin Choi, M.D.

    Asan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 28, 2010

First Posted

August 10, 2010

Study Start

July 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

August 10, 2010

Record last verified: 2010-06

Locations

KR(1)