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

NCT ID: NCT05245630

Last Updated: 2022-02-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 59 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2022-01-31

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.

Conditions

Lung Cancer; Lung Diseases; Adenocarcinoma of Lung

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Robotic arm assisted PET/CT guided biopsy

Intervention Type: 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

Intervention Type: PROCEDURE

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

Robotic arm assisted PET/CT guided biopsy

Intervention Type: 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

Intervention Type: PROCEDURE

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

Interventions

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.

Intervention Type: PROCEDURE

PET fused CT-Fluoroscopy guided biopsy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Post Graduate Institute of Medical Education and Research, Chandigarh

OTHER

Sponsor Role: lead

Responsible Party

Rajender Kumar

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Nuclear Medicine, PGIMER

Chandigarh, Chandigarh, India

Countries

India

Other Identifiers

NK/6832/MD/594

Identifier Type: -

Identifier Source: org_study_id