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Completed

NCT Number: NCT02009319

Endobronchial Ultrasound Elastography: the Utility of Strain Ratio for Lymph Node Staging in Lung Cancer Patients

The aim of this pilot study is to evaluate EBUS elastography strain ratio in assessment of mediastinal lymph nodes in patients with suspicion for lung cancer for the first time. Strain ratios of mediastinal lymph nodes will be compared with EBUS B-mode features and with tissue diagnosis as a gold standard.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Clinic of Pulmonary and Allergic Diseases Golnik

Golnik, 4204, Slovenia

About this study

Evaluation will be performed on consenting consecutive patients at least 18 years old, referred to bronchoscopy with suspicion for lung cancer according to chest CT-scan. Eligible patients should have either enlarged discrete N2/N3 lymph nodes, or central tumor or enlarged N1 lymph nodes with normal mediastinal lymph nodes. Exclusion criteria will be metastatic disease, severe co-morbidity that disqualified surgical treatment, mediastinal infiltration by tumor and small peripheral lung tumor with normal-sized mediastinal lymph nodes.

Outcomes: Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV) for probability of malignant lymph node diagnosis, determined by elastography strain ratio. Receiver operating characteristic (ROC) analysis will be made to display specificity / sensitivity for different strain ratio cut-off values. Area under the ROC curve will be calculated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • enlarged discrete N2/N3 lymph nodes
  • central tumor with normal mediastinal lymph nodes
  • enlarged N1 lymph nodes with normal mediastinal lymph nodes

Exclusion criteria

  • metastatic disease
  • severe co-morbidity that disqualified surgical treatment
  • mediastinal infiltration by tumor
  • small peripheral lung tumor with normal-sized mediastinal lymph nodes

Treatment and study plan

Primary outcomes

  1. elastography strain ratio

    Time frame: up to 7 months

    Sensitivity, specificity, accuracy, positive predictive value (PPV) and negative predictive value (NPV)

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2013
Registry last updated
Sep 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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