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Optical Biopsy for Thoracic Lymph Nodes.

NCT02689050 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2017-09-20

No results posted yet for this study

Summary

EUS-FNA is the recommended diagnostic examination of choice when patients present with suspected lower mediastinal lymph nodes on imaging. EUS-FNA is minimal invasive and low in costs, and although it has a good record in detecting diseases (eg confirm a nodal metastasis or granulomas) it has limitations in excluding diseases (missing metastases/ or granulomas) resulting in a false negative rate of 15-20%. Substantial limitations that most likely can be attributed to areas within the node that are not sampled during EUS-FNA tissue acquisition. Improved needle based EBUS/ EUS guided nodal diagnostics might result in improved quality of the fine needle aspirations, reduce in surgical diagnostic procedures , reduced costs and result in a shorter timebefore-treatment interval.

Conditions

  • Mediastinal Lymphadenopathy
  • Non-small Cell Lung Carcinoma
  • Sarcoidosis

Interventions

DEVICE

Needle based confocal laser endomicroscopy (nCLE)

During the fine needle aspiration of a suspected and a non-suspected lymph node we will obtain needle based CLE (nCLE) images within the lymph node. Fine needle aspirations will be obtained after the optical biopsy measurements. We will compare the results of the optical biopsy with the cytology results, or to histology in case an additional surgery is indicated.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Jouke T Annema, MD, PhD · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-01-13
Primary Completion
2017-03-22
Completion
2017-03-22

Countries

  • Netherlands

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 NCT02689050 on ClinicalTrials.gov