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Recruiting NCT06923098

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

No phase Interventional Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: PET-CT guided biopsy, CT guided biopsy.
Who it may be relevant to
Registry conditions: Lung Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
India
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Procedure PET-CT guided biopsy
    PET-CT guided biopsy of lung lesions
  • Procedure CT guided biopsy
    CT guided biopsy of lung lesions

Primary outcome measures

  • Inconclusive pathology findings [Time frame: 1 month]
Secondary outcome measures (1)
  • Incidence of pneumothorax and hemoptysis [Time frame: 1 month]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

India · 1 center
  • All India Institute of Medical Sciences, Bhubaneswar — Bhubaneswar

Identifiers

NCT: NCT06923098 · IEC/AIIMS BBSR/PG Thesis/2023-

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗