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NCT Number: NCT07060378

A Study of Contrast-enhanced EBUS in Lung Lesions and Intrathoracic Lymph Nodes

Exploring the Clinical Application Value of Contrast Enhancement Features in CE-EBUS Images for the Diagnosis of Pulmonary Lesions and Intrapulmonary Lymph Nodes

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age >18 years old;
  • Enlargement of at least one intrathoracic LN (short diameter > 1 cm) or central parenchymal lung lesions adjacent to the airway detected on chest CT, or increased fluorodeoxyglucose uptake in at least one intrathoracic lymph node on PET / CT (standardized uptake value > 2.5);
  • CP-EBUS-TBNA is required to determine the diagnosis or staging, the patient agreed to undergo CE-EBUS, and there were no contraindications to EBUS-TBNA;
  • Patients who have good compliance and sign informed consent.

Exclusion criteria

  • Patients with known hypersensitivity to ultrasound contrast components;
  • Patients with severe pulmonary hypertension (pulmonary artery pressure > 90 mmHg);
  • Patients with angina pectoris, acute coronary syndrome, clinically unstable ischemic heart disease, heart failure, cardiac dysfunction, and cardiac disease with right-to-left shunting;
  • Patients with uncontrolled essential hypertension and adults with respiratory distress syndrome;
  • Pregnant or lactating women;
  • Patients with contraindications to bronchoscopy;
  • Patients with other conditions that, in the opinion of the investigator, make the patient unsuitable for the study.

Treatment and study plan

Contrast-enhanced endobronchial ultrasound

Device

Using CE-EBUS to observe pulmonary lesions and abnormal enlarged intrathoracic lymph nodes, the enhancement characteristics of benign and malignant lesions under CE-EBUS were extracted for both conditions.

Primary outcomes

  1. Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy

    Time frame: 6 month post-procedure

    Diagnostic accuracy is defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using CE-EBUS interpretation criteria.

  2. Diagnostic accuracy of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions

    Time frame: 6 month post-procedure

    Diagnostic accuracy was defined as the number of lesions correctly identified as malignant or benign divided by the total number of lesions using the CE-EBUS interpretation criteria.

Secondary outcomes

  1. Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrathoracic lymphadenopathy

    Time frame: 6 months post-procedure

    Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.

    Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.

    Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.

    Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.

  2. Sensitivity, specificity, positive predictive value and negative predictive value of CE-EBUS in the differential diagnosis of benign and malignant intrapulmonary lesions

    Time frame: 6 months post-procedure

    Sensitivity is defined as the number of lesions correctly identified as malignant using the CE-EBUS interpretation criteria divided by the total number of malignant lesions.

    Specificity is defined as the number of lesions correctly identified as benign using the CE-EBUS interpretation criteria divided by the total number of benign lesions.

    Positive predictive value is the percentage of truly malignant lesions among all lesions identified as malignant using the CE-EBUS interpretive criteria.

    Negative predictive value is the percentage of truly benign lesions among all lesions identified as benign using CE-EBUS interpretive criteria.

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Chest Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Jul 11, 2025
Registry last updated
Jul 11, 2025

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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