Lung Diseases
Conditions
Keywords
CT guided biopsy, PET-CT guided biopsy, Lung lesions
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.
Interventions
PROCEDUREPET-CT guided biopsy
PET-CT guided biopsy of lung lesions
PROCEDURECT guided biopsy
CT guided biopsy of lung lesions
Sponsors
All India Institute of Medical Sciences, Bhubaneswar
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inconclusive pathology findings | 1 month | Comparing the proportion of inconclusive pathology reports in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of pneumothorax and hemoptysis | 1 month | Incidence of pneumothorax and hemoptysis in both arms |
Countries
India
Outcome results
None listed