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

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Brief Title

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

Official Title

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.

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

 To compare the radiation exposure and complication in the both arms

Condition

Lung Cancer

Intervention

Robotic arm assisted PET/CT guided biopsy

Study Arms / Comparison Groups

 Robotic arm assisted PET/CT guided biopsy
Description:  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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

59

Start Date

July 1, 2020

Completion Date

January 31, 2022

Primary Completion Date

December 31, 2021

Eligibility Criteria

        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
      

Gender

All

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 

Location Countries

India

Location Countries

India

Administrative Informations


NCT ID

NCT05245630

Organization ID

NK/6832/MD/594


Responsible Party

Principal Investigator

Study Sponsor

Postgraduate Institute of Medical Education and Research


Study Sponsor

, , 


Verification Date

February 2022