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

NCT06923098 | Recruiting

• 1 other identifier: IEC/AIIMS BBSR/PG Thesis/2023-
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

CT guided biopsy; PET-CT guided biopsy; Lung lesions

Outcome Measures

Primary Outcomes (1)

• Inconclusive pathology findings

  Comparing the proportion of inconclusive pathology reports in both arms

  1 month

Secondary Outcomes (1)

• Incidence of pneumothorax and hemoptysis

  1 month

Study Arms (2)

CT guided biopsy

ACTIVE COMPARATOR

Procedure: CT guided biopsy

PET-CT guided biopsy

EXPERIMENTAL

Procedure: PET-CT guided biopsy

Interventions

PET-CT guided biopsy PROCEDURE

PET-CT guided biopsy of lung lesions

PET-CT guided biopsy

CT guided biopsy PROCEDURE

CT guided biopsy of lung lesions

CT guided biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 11, 2025
• Study Start: July 1, 2023
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

IN (1)