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NCT Number: NCT06923098

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

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

All India Institute of Medical Sciences, Bhubaneswar

Bhubaneswar, Odisha, 751019, India

Location status: Recruiting

Location contact

Dr Girish Kumar Parida, MD

CONTACT

[email protected]

+91 9968856817

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PET-CT guided biopsy

Procedure

PET-CT guided biopsy of lung lesions

CT guided biopsy

Procedure

CT guided biopsy of lung lesions

Primary outcomes

  1. Inconclusive pathology findings

    Time frame: 1 month

    Comparing the proportion of inconclusive pathology reports in both arms

Secondary outcomes

  1. Incidence of pneumothorax and hemoptysis

    Time frame: 1 month

    Incidence of pneumothorax and hemoptysis in both arms

Sponsors and collaborators

Lead sponsor

All India Institute of Medical Sciences, Bhubaneswar

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 11, 2025
Registry last updated
Apr 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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