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Completed

NCT Number: NCT05245630

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

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.

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Carcinoma Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Nuclear Medicine, PGIMER

Chandigarh, 160012, India

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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 the written informed consent
  • Signs of hypoperfusion like cyanosis, hypotension etc.
  • Presence of hypoxemia (SpO2 < 95% -measured in a pulse oximeter)
  • Pregnant/Lactating females participants
  • Non-cooperative participants
  • Inaccessible lesions (based on the decision made on pre-biopsy planning)
  • CoVID-19 positive participants

Treatment and study plan

Robotic arm assisted PET/CT guided biopsy

Procedure

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.

PET fused CT-Fluoroscopy guided biopsy

Procedure

CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion

Primary outcomes

  1. 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

    Time frame: three months

    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.

Secondary outcomes

  1. To compare the radiation exposure and complication in the both arms

    Time frame: three months

    Procedure related complications and radiation exposure to the participants and interventionist were noted in the both arms.

Sponsors and collaborators

Lead sponsor

Post Graduate Institute of Medical Education and Research, Chandigarh

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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