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

A

All India Institute of Medical Sciences, Bhubaneswar

Status

Enrolling

Conditions

Lung Diseases

Treatments

Procedure: PET-CT guided biopsy
Procedure: CT guided biopsy

Study type

Interventional

Funder types

Other

Identifiers

NCT06923098
IEC/AIIMS BBSR/PG Thesis/2023-

Details and patient eligibility

About

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.

Enrollment

108 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

108 participants in 2 patient groups

CT guided biopsy
Active Comparator group
Treatment:
Procedure: CT guided biopsy
PET-CT guided biopsy
Experimental group
Treatment:
Procedure: PET-CT guided biopsy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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