An observational study in Lung Cancer, Lung Diseases and Adenocarcinoma of Lung, sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh. Completed at 1 site in India. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-18.
Sponsored by Post Graduate Institute of Medical Education and Research, Chandigarh · Observational
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.
303 studies on the registry are indexed under Adenocarcinoma of Lung; 78 are open to participants now.
This study's enrollment of 59 is below the median of 200 across 80 observational studies indexed under Adenocarcinoma of Lung.
Browse Adenocarcinoma of Lung studies →Post Graduate Institute of Medical Education and Research, Chandigarh is the lead sponsor of 290 studies on the registry; 42 are open to participants now.
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The participants attending the pulmonary medicine department with clinical suspicion of lung lesions were referred to the Department of Nuclear Medicine for lung biopsies were recruited for the study. The participants were randomly assigned to either of the two intervention arms. Baseline heart rate, blood pressure, oxygen saturation and respiratory system examination were done for all the participants included in the study.
Exclusion Criteria:
In this group, participants were recruited for robotic-assisted PET/CT guided biopsy from the FDG avid lung lesions. biopsies were done using an automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) to guide the needle for biopsy. It is a robotic arm with a four-ax guide arm and a planning console. Pre-interventional fused PET/CT images from Biograph mCT 16 scanner were sent via LAN cable to the device (MAXIO-EX) console.
Procedure: Robotic arm assisted PET/CT guided biopsy · Procedure: PET fused CT-Fluoroscopy guided biopsy
In this group, participants were recruited for PET fused CT-Fluoroscopy guided biopsy from the FDG avid lung lesions. A biopsy needle was placed to the target lesion on PET/CT under CT fluoroscopy
Procedure: Robotic arm assisted PET/CT guided biopsy · Procedure: PET fused CT-Fluoroscopy guided biopsy
After preparing the participant for the procedure, the participant was positioned on the PET/CT table with the immobilizer. An automated robotic arm (MAXIO-EX, Perfint healthcare Pvt Ltd, Chennai, India) was used to guide the needle for biopsy. Co-axial 18 G biopsy needle (BARD Biopsy disposable coaxial biopsy needle pack, Bard Peripheral Vascular, Inc., Arizona, USA) was inserted according to the orientation planned by the robotic biopsy device. After the location is ensured, the trocar stylet is removed from the coaxial cannula and specimens were retrieved using a semiautomated biopsy gun. A repeat CT chest was acquired two hours after the procedure to rule out post-procedural complications. Complications during the procedure were noted, and immediate management was done.
CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion
To compare the accuracy ( in percentage) of trans-thoracic percutaneous PET fused CT-fluoroscopy guided lung biopsy and automated robotic arm assisted PET/CT guided lung biopsy
Histology reports of the biopsies were recorded and the mutation analysis, Adequacy of the sample was decided by the pathologist who received the sample and when inadequate, we were notified accordingly by the Department of Pathology. The histopathological results were analyzed. True positive, True negative False-positive and False-negative were calculated for both the groups. The diagnostic accuracy in percentage for both arms will be calculated and compared.
Time frame: three months
To compare the radiation exposure and complication in the both arms
Procedure related complications and radiation exposure to the participants and interventionist were noted in the both arms.
Time frame: three months
Plan to share: No — Data generated or analyzed during the study are available from the primary investigator on a valuable and genuine request.
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Post Graduate Institute of Medical Education and Research, Chandigarh