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

February 24, 2025 updated by: Chang Gung Memorial Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pre-operative CT scans will be used for localization planning. The images will be reviewed by our team to determine optimal placement of wires or indocyanine green. After induction of general anesthesia and insertion of a double-lumen tube, the patient will be placed in either supine, prone or lateral decubitus position. Under end-inspiratory breath-hold, an initial 30 second rotary scan for surgical planning will be obtained. The puncture path will be planned to be as short as possible while avoiding transfissural punctures or being oriented towards major vascular structure. The skin entry site for the planned needle puncture route will then identified under the guidance of the referential metallic marker. An 18-gauze marker needle will be gradually advanced under CT-guidance until it reached the target lesion. A total of 0.3 ml ICG dye(for superficial lesion) or microcoil or hookwire(for deeper lesion) will then be used to localize the tumor.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 333
        • Chang Gung Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

<1 cm, those at a distance more than 1.5 cm from the lung periphery, or ground-glass opacity (GGO) lung lesion.

Exclusion Criteria:

Age <20 serious pulmonary heart disease more than one tumors needed localization

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: localization
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
Procedure: localization
small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure time
Time Frame: from initiation of the procedure time (first time CT scanning) to the end (localization complete).
Recording the time of localization procedure, including needle puncture time.
from initiation of the procedure time (first time CT scanning) to the end (localization complete).
success rate of localization
Time Frame: from initiation of localization to completion of surgery
Recording the result of localization (success or not), the failure reason, and the deviation distance
from initiation of localization to completion of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiation dose
Time Frame: from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 1 year.
Effective dose estimates were performed using thermoluminescent dosimeters (TLD).
from initiation of the preprocedural CT scanning to the end of the postprocedural CT scanning, through study completion, an average of 1 year.
Complication rate
Time Frame: from initiation of localization to completion of surgery
Recording the rate of common complications, such as pneumothorax, hemothorax.
from initiation of localization to completion of surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chang Gung Memorial Hospital

Investigators

  • Study Chair: Yin-Kai Chao, MD, Ph D, Chang Gung Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Actual)

June 30, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

July 21, 2021

First Submitted That Met QC Criteria

July 21, 2021

First Posted (Actual)

July 23, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 24, 2025

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202100442A3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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