PET/CT GUIDED BIOPSY VERSUS CT GUIDED BIOPSY IN EVALUATION OF SUSPECTED LUNG NEOPLASMS

Not Applicable

Recruiting

• Conditions: Lung Diseases

• Registration Number: NCT06923098
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

Percutaneous CT guided biopsy is a well-established, standard sampling technique for suspected neoplastic lesions located in peripheral region in lung parenchyma. Inconclusive results on CT guided biopsy is substantially higher in large lung lesions which are prone to cause peripheral pneumonia, atelectasis and even regional necrosis, which are hard to be distinguished from tumor on CT images.

Functional imaging guided biopsy like PET/CT guided biopsy identifies areas of highest concentration of neoplastic cells and provides accurate results. Only a few studies have been done regarding PET/CT guided biopsy and studies omparing PET/CT guided and CT guided percutaneous transthoracic lung biopsy are very few and this study would be a randomized trial comparing these diagnostic modalities in terms of diagnostic yield, diagnostic accuracy of sample and complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-07-01
• Status Verified: 2025-04
• Study First Submitted: 2025-04-04
• Study First Submitted QC: 2025-04-04
• Last Update Submitted: 2025-04-04
• Study First Posted: 2025-04-11
• Last Update Posted: 2025-04-11
• Primary Completion: 2025-07
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• Age above 18 years
• INR < 1.2 and platelet counts > 80,000/mm3
• CT thorax with lung lesion more than 10 mm.
• Accessible lesions for CT-guided biopsy.

Exclusion Criteria

• Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by -INR ≥1.2 and Platelet counts ≤ 80,000/mm3
• Participants who refuse to provide consent
• Signs of hypoperfusion like hypotension, cyanosis etc.
• Presence of hypoxemia with SpO2 < 94 %- measured in a pulse oximeter)
• Pregnant/Lactating female subjects
• Non-cooperative subjects
• Lesions that are inaccessible (decision made on pre-biopsy planning)
• Serum creatinine level more than 2mg/dl.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Inconclusive pathology findings	1 month	Comparing the proportion of inconclusive pathology reports in both arms

Secondary Outcome Measures

Name	Time	Method
Incidence of pneumothorax and hemoptysis	1 month	Incidence of pneumothorax and hemoptysis in both arms

Trial Locations

Locations (1)

All India Institute of Medical Sciences, Bhubaneswar; 🇮🇳 Bhubaneswar, Odisha, India