NCT04974632

Mobile 3D C-arm CT for Lung Tumor Localization Efficacy Analysis: a Prospective Clinical Trial

Completed NA Last updated 26 February 2025

What this trial tests

NA trial testing localization in Lung Tumor in 41 participants. Completed in 30 June 2022.

Timeline

1 July 2021

Primary endpoint
30 June 2022

30 June 2022

Quick facts

Lead sponsor	Chang Gung Memorial Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	41
Start date	1 July 2021
Primary completion	30 June 2022
Estimated completion	30 June 2022
Sites	1 location across Taiwan

Drugs / interventions tested

• localization

Conditions studied

• Lung Tumor — all drugs for Lung Tumor →
• Thoracoscopic Surgery — all drugs for Thoracoscopic Surgery →

Sponsor

Chang Gung Memorial Hospital

Who can join

20 and older, any sex, with Lung Tumor or Thoracoscopic Surgery. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

It is well known that video-assisted thoracoscopic surgery (VATS) is preferred to open surgery for lung resection because of the smaller incisions and optimized postoperative recovery, including a shorter length of hospitalization and much decreased local tenderness. Studies have shown less operative and post-operative morbidity with decreased operative times. However, for small nodules (i.e. lesions \<1 cm or those at a distance more than 1.5cm from the lung periphery), adequate identification of the target nodule has been being difficult by VATS with necessity of more significant resection or thoracotomy conversion to ensure complete tumor resection.

In order to improve nodule localization, a variety of preoperative localization methods such as CT-guide hook wire or methyl blue dye localization have been proposed. It has been proved to be much easier to mark lung nodules and help guide resection during VATS. However, there are certain concerns. First, it is difficult to minimize the time between the localization procedure and the subsequent surgery in reality. Second, there is concern for patient safety, in particular pneumothorax or hemothorax, during transferred to and from the ward to the radiology suit and in the frequent delays and waiting in reception areas prior to transfer to operating theaters. Finally, interdepartmental transfers and delays can also increase the risk of hook wire dislodgement.

Theoretically, the aforementioned disadvantage could be solved by performing the localization procedure and the lung surgery in the same operating room environment. We performed single-step localization and removal of small pulmonary nodules in the hybrid OR equipped with floor-mounted C-arm cone-beam computed tomography (CBCT) in the previous study. However, it costed a lot of money and every localization could only be performed in the hybrid OR. Mobile 3D C-arm CT is another form of CBCT. It depicts soft tissues with high contrast but also offer a more affordable solution with relative low cost. In this case series, we will investigate the use of a mobile 3D C-arm CT for single-step localization and removal of small pulmonary nodules.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility and Efficacy of Mobile Three-Dimensional c-Arm Systems for Single-Stage Localization and Resection of Small Pulmonary Nodules: A Pilot Clinical Trial.
   Fang HY, Cheng C, Chou PL, Chao YK. · · 2026 · PMID 41428415 · DOI 10.1093/icvts/ivaf313