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

NCT05245630 | Completed DMC

• 1 other identifier: NK/6832/MD/594
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer; Lung Diseases; Adenocarcinoma of Lung

Outcome Measures

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

  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 Outcomes (1)

• To compare the radiation exposure and complication in the both arms

  three months

Study Arms (2)

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; Procedure: PET fused CT-Fluoroscopy guided biopsy

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

Interventions

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; Robotic arm assisted PET/CT guided biopsy

PET fused CT-Fluoroscopy guided biopsy PROCEDURE

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

PET fused CT-Fluoroscopy guided biopsy; Robotic arm assisted PET/CT guided biopsy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Post Graduate Institute of Medical Education and Research, Chandigarh: lead

Study Sites (1)

Department of Nuclear Medicine, PGIMER

Chandigarh, Chandigarh, 160012, India

Location

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Adenocarcinoma of Lung

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: February 18, 2022
• Study Start: July 1, 2020
• Primary Completion: December 31, 2021
• Study Completion: January 31, 2022
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)