Percutaneous Lung Biopsy Using Cone Beam CT With Virtual Guidance: a Randomized Control Trial

NCT04299542 | Completed DMC

• 1 other identifier: VIR-19-11
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

Image-guided percutaneous lung biopsy is an essential procedure in lung cancer management, where it is integral to confirming the diagnosis and determining tumour histology. An ideal percutaneous lung biopsy also needs to have a short procedure time with accurate needle placement to minimize the inherent risk of the procedure. Since the 1970s, conventional Multi-detector CT (MDCT) has been the modality of choice in percutaneous lung biopsy. Recent research has proposed CT fluoroscopy and cone-beam CT (CBCT) as alternative methods. Virtual guidance has been developed to improve target visibility and access for these complex cases. More specifically, it plans a potential computed 3D needle path before the procedure, using the CBCT images. This 3D path can be transposed onto real time fluoroscopic images to guide the biopsy, thus potentially improves patients' safety due to more accurate needle placement.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• The number of needle repositioning to reach the target

  This will be recorded during procedure

  immediately after completion of procedure

Secondary Outcomes (3)

• procedure time

  immediately after completion of procedure

• radiation dose

  immediately after completion of procedure

• complication

  1 month after completion of procedure

Study Arms (2)

conventional Multi-detector CT (MDCT)

ACTIVE COMPARATOR

Percutaneous lung biopsy using MDCT

Procedure: Percutaneous lung biopsy using conventional MDCT

cone-beam CT (CBCT)

ACTIVE COMPARATOR

Percutaneous lung biopsy using CBCT

Procedure: Percutaneous lung biopsy CBCT

Interventions

Percutaneous lung biopsy using conventional MDCT PROCEDURE

Conventional CT biopsy will be performed using a 64 slice CT scanner. A preliminary plain CT is acquired covering the entire target lesion with a skin marker, and the interventional radiologist would decide on the skin puncture site and the needle pathway. A post-procedural CT scan will be made to detect pneumothorax or pulmonary haemorrhage. All images will be archived in the picture achieving and communication system (PACS).

conventional Multi-detector CT (MDCT)

Percutaneous lung biopsy CBCT PROCEDURE

CBCT guided biopsy will be performed in the angiography suite. A preliminary CBCT (DynaCT) is acquired covering the entire target lesion is first performed. Image data will be displayed and processed using Syngo iGuide system. A potential needle trajectory will be drawn from skin to lesion. Integration of the cross-sectional images and real time fluoroscopy will result in three system positions: one bull's eye view and two progression views. During fluoroscopy, the planned needle trajectory and target will be overlaid on the real time fluoroscopy image. After the needle reaches the target, another CBCT will be performed to confirm needle position. Biopsy using coaxial system and post-procedural CT scans will be performed in similar fashion as the conventional CT group.

cone-beam CT (CBCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Solitary or multiple lung lesions (solid or subsolid nodule, pulmonary infiltrate) ≥1cm

You may not qualify if:

• Patient \<18 years old
• Patient not able to give informed consent
• Uncooperative patient who is unable to hold still or hold their breath for safe biopsy
• Lesions \<1cm
• Lesions within 1cm of vital thoracic structures such as the great vessels and the mediastinum
• Peripheral lesions accessible to biopsy with ultrasound guidance

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong

Hong Kong, Hong Kong

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Simon Yu, Professor

  DIIR, CUHK, Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Study Start: May 4, 2020
• Primary Completion: November 22, 2021
• Study Completion: November 22, 2021
• Last Updated: October 21, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)