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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases; Lung Cancer; Adenocarcinoma of Lung
• Intervention / Treatment: Procedure: Robotic arm assisted PET/CT guided biopsy; Procedure: PET fused CT-Fluoroscopy guided biopsy

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
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• India
  • Chandīgarh
    • Chandigarh, Chandīgarh, India, 160012
      • Department of Nuclear Medicine, PGIMER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Robotic arm assisted PET/CT guided biopsy; 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; 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.; Procedure: PET fused CT-Fluoroscopy guided biopsy; CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion
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; 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.; Procedure: PET fused CT-Fluoroscopy guided biopsy; CT fluoroscopy was used to place the biopsy needle to the FDG avid lung lesion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	three months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Medical Education and Research

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): January 31, 2022

Study Registration Dates

• First Submitted: February 8, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 8, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Lung Diseases; Adenocarcinoma of Lung
• Other Study ID Numbers: NK/6832/MD/594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data generated or analyzed during the study are available from the primary investigator on a valuable and genuine request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No