Comparison of Robotic Arm-assisted PET/CT-guided Lung Biopsy With PET Fused CT- Fluoroscopy-guided Lung Biopsy

Comparison of Real-time Robotic Arm-assisted 18F-FDG PET/CT-guided Lung Biopsy Versus PET Fused CT- Fluoroscopy-guided Lung Biopsy: a Randomized Trial to Assess Diagnostic Performance and Patient Safety.

Patients with suspicious lung lesions were undertaken for PET/CT directed under CT fluoroscopy lung biopsy or robotic-assisted biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.

Patients with clinical suspicion of lung lesions were recruited for FDG PET/CT. Based on the PET/CT findings and clinical details a PET/CT guided biopsy was planned. The patients were assigned to the two arms. In the first arm, participants underwent a robotic-assisted biopsy. In the second arm, participants underwent PET/CT-directed CT fluoroscopy-guided lung biopsy. The biopsy planning including patient positioning was done after F18-FDG PET/CT whole body or regional imaging of the patient. Written consent was obtained and the patient will be prepared for the biopsy. Lung biopsies were done using a semi-automatic biopsy gun under the imaging guidance (PET fused CT fluoroscopy) following aseptic precautions. Follow-up CT scans were taken post-biopsy. The time consumed for the procedure, radiation exposure to the interventionist, complications and diagnostic yield in both the arms were compared.

Inclusion Criteria:

1. Age >/= 18 years
2. FDG avid amenable lung lesion
3. INR < 1.2 and Platelet counts > 80,000/mm3

Exclusion Criteria:

1. Participants with pre-existing bleeding diathesis like hemophilia, coagulopathy defined by INR ≥ 1.2 and Platelet counts ≤ 80,000/mm3
2. Participants who refuse to provide the written informed consent
3. Signs of hypoperfusion like cyanosis, hypotension etc.
4. Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)
5. Pregnant/Lactating females participants
6. Non-cooperative participants
7. Inaccessible lesions (based on the decision made on pre-biopsy planning)
8. CoVID-19 positive participants