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

NCT ID: NCT06923098

Last Updated: 2025-04-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-01
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CT guided biopsy

Group Type: ACTIVE_COMPARATOR

CT guided biopsy

Intervention Type: PROCEDURE

CT guided biopsy of lung lesions

PET-CT guided biopsy

Group Type: EXPERIMENTAL

PET-CT guided biopsy

Intervention Type: PROCEDURE

PET-CT guided biopsy of lung lesions

Interventions

PET-CT guided biopsy

PET-CT guided biopsy of lung lesions

Intervention Type: PROCEDURE

CT guided biopsy

CT guided biopsy of lung lesions

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

All India Institute of Medical Sciences, Bhubaneswar

OTHER

Sponsor Role: lead

Responsible Party

Girish Kumar Parida

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, India

Site Status: RECRUITING

Countries

India

Facility Contacts

Dr Girish Kumar Parida, MD

Role: primary

grissh135@gmail.com

+91 9968856817

Other Identifiers

IEC/AIIMS BBSR/PG Thesis/2023-

Identifier Type: -

Identifier Source: org_study_id