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Clinical Trials/CTRI/2024/11/076528
CTRI/2024/11/076528Not yet recruitingNot Applicable

COMPARISON OF PET-CT AND ENDOBRONCHIAL ULTRASOUND WITH SURGICAL HISTOPATHOLOGY FOR MEDIASTINAL NODAL STAGING OF NON-SMALL CELL LUNG CANCER IN PATIENTS UNDERGOING SURGERY

AIIMS New Delhi1 site in 1 country160 target enrollmentStarted: November 11, 2024Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
160
Locations
1
Primary Endpoint
To find out the diagnostic accuracies of PET-CT,EBUS compared to surgical histopathology for mediastinal nodal staging of NSCLC. Surgical histopathology will be taken as gold standard.

Study Overview

Brief Summary

Lung cancer is the leading cause of cancer (globally) incidence and mortality, accounting for an estimated 2 million diagnoses and 1.8 million deaths and also leading cause of cancer mortality worldwide.

After initial diagnosis of NSCLC patients undergo for staging with PETCT as the treatment of NSCLC depending on the stage of the disease includes surgical resection with curative intent in early-stage disease and chemoradiation in advanced stage disease. For surgically resect-able cases EBUS is done to stage mediastinum to exclude mediastinal lymph-nodal involvement because for N2 disease there are two options of treatment either definitive chemo-radiation or NACT/NACTRT followed by assessment and surgery for selected patients. For mediastinal staging both the above mentioned tests have its own drawbacks. Studies show when both tests are  used together , a better staging of mediastinum is followed. As EBUS-TBNA may identify additional malignant LNs (7.4%), and this highlights the risk for false-negative findings with PET scanning in isolation. Also there are stations (like station 5/6/8/9) where EBUS cant sample.

The study aims to see the accuracies of PET-CT and EBUS  when they are compared to post-surgical histopathological examination report. Thus this study will provide sensitivity, specificity , positive and negative predictive value of both the tests and how these tests contribute to proper mediastinal staging.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
0.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • All NSCLC lung undergoing surgery after mediastinal nodal evaluation.

Exclusion Criteria

  • Small cell lung cancer
  • Metastatic NSCLC
  • Dual primary malignancy
  • Recurrent NSCLC
  • Not giving consent for PETCT, EBUS-TBNA, or surgery
  • Received partial treatment outside AIIMS.

Outcomes

Primary Outcomes

To find out the diagnostic accuracies of PET-CT,EBUS compared to surgical histopathology for mediastinal nodal staging of NSCLC. Surgical histopathology will be taken as gold standard.

Time Frame: at time of post op HPE analysis

Secondary Outcomes

  • To find out and compare the sensitivity, specificity, positive predictive value, and negative predictive value of PET-CT, EBUS . Surgical histopathology will be taken as gold standard(2 years)

Investigators

Sponsor
AIIMS New Delhi
Sponsor Class
Government medical college
Responsible Party
Principal Investigator
Principal Investigator

Shaon Das

AIIMS , New Delhi

Study Sites (1)

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