Prospective Radiological Study of HRCT to Predict Pathological Noninvasiveness in NSCLC

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Adenocarcinoma of lung
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Boehringer Ingelheim – Adenocarcinoma of lung
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Brief Title

HRCT in Prediction of Tumor Invasion in GGO Lung Adenocarcinoma

Official Title

Preoperative Evaluation of High-resolution Computed Tomography to Predict Pathologic Tumor Invasion in Ground-glass Opacity Featured Lung Adenocarcinoma

Brief Summary

      This study aims to evaluate the correlation between radiological diagnosis based on HRCT and
      pathological invasiveness.Investigators observe the radiological features and the correlation
      with the postoperative pathological findings.

Detailed Description

      Preoperative evaluation of pathologic tumor invasion of ground glass opacity (GGO) featured
      lung adenocarcinoma is important for selection of appropriate surgical extent. Whether
      thoracic high-resolution computed tomography (HRCT) scan could precisely predict pathologic
      tumor invasion remains unknown. Patients with peripheral GGO nodules (GGNs) would be
      enrolled, and HRCT with target scan would be performed preoperatively. Pathologic tumor
      invasion (invasive adenocarcinoma [IAD] versus adenocarcinoma in situ [AIS]/minimally
      invasive adenocarcinoma [MIA]) would be evaluated according to radiologic parameters of HRCT
      before surgery. Primary endpoint of this trial is the diagnostic sensitivity of pathologic
      tumor invasion evaluated by HRCT. Secondary endpoint is the diagnostic value of radiologic
      parameters of HRCT for pathologic tumor invasion of GGO featured lung adenocarcinoma.

Study Type

Observational

Primary Outcome

Sensitivity

Secondary Outcome

 Value of radiologic parameters for tumor invasion

Condition

Adenocarcinoma of Lung

Study Arms / Comparison Groups

 patients
Description:  Patients with lung cancer who are candidates for surgery.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Estimated Enrollment

620

Start Date

November 18, 2019

Completion Date

July 1, 2021

Primary Completion Date

April 30, 2021

Eligibility Criteria

        Inclusion Criteria:

        (1) GGNs on HRCT scan; (2) clinical stage IA; (3) simultaneously no more than three
        nodules; (5) Age ranging from 15 to 85 years.

        Exclusion Criteria:

        (1) pathologically confirmed non-adenocarcinoma; (2) patients who did not receive surgery.

Gender

All

Ages

15 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Haiquan Chen, ,

Location Countries

China

Location Countries

China

Administrative Informations

NCT ID

NCT04165759

Organization ID

PRSHRCT

Responsible Party

Principal Investigator

Study Sponsor

Fudan University

Collaborators

 Fujian Medical University Union Hospital

Study Sponsor

Haiquan Chen, Principal Investigator, Fudan University

Verification Date

November 2021