Cone-Beam CT Guided Localization for Lung Cancer

Overseen By Judy McConnell

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Disqualifiers: Pregnancy, Implantable devices, Severe obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging technology called Cone-Beam CT to assist doctors in placing tiny markers in the lungs before surgery. The goal is to facilitate the precise removal of small lung nodules. The trial suits adults with lung nodules planning to undergo a specific type of lung surgery called VATS. Participants should be comfortable with general anesthesia and should not have certain medical devices that the technology could affect. As an unphased trial, this study allows participants to contribute to innovative research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this Cone-Beam CT technique is safe for lung cancer localization?

Research has shown that using cone-beam CT (CBCT) to guide marker placement in lung surgery is generally safe. One study found that marking lung nodules with CBCT before surgery was effective and well-tolerated by patients. Another report noted that patients with small lung nodules marked using CBCT experienced few complications. Most patients managed the procedure well, with only minor issues like temporary pain at the site.

The safety of microcoil placement with CBCT has also been studied. Research suggests this method is safe and helps surgeons accurately locate lung nodules during surgery. Overall, both CBCT and microcoil placement have demonstrated promising safety results in previous studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Cone Beam CT Guided Localization for lung cancer because it offers a more precise method for targeting tumors. Unlike traditional imaging techniques, Cone Beam CT provides a 3D view of the lung, allowing for accurate placement of a microcoil, which can improve the precision of subsequent surgical or therapeutic interventions. This technique aims to enhance the accuracy of tumor localization, potentially leading to better outcomes and fewer complications compared to conventional methods.

What evidence suggests that Cone Beam CT is effective for lung cancer?

Research has shown that using cone-beam CT (CBCT) to guide the placement of tiny markers, called microcoils, for lung cancer surgery is both effective and safe. Studies have found that this method accurately pinpoints small lung nodules with a success rate of 97-98%. This technique precisely marks the nodules, making them easier to remove during surgery. Additionally, it results in fewer complications compared to other methods. Participants in this trial will undergo CBCT-guided microcoil placement, which previous findings suggest is a dependable option for assisting lung surgeries. ^{1 2 4 5 6}

Are You a Good Fit for This Trial?

Adults over 18 with lung nodules set for microcoil localization before VATS wedge resection can join. Excluded are those who can't consent, tolerate anesthesia, pregnant individuals, patients with RF-sensitive implants, and severely obese patients.

Inclusion Criteria

I am an adult with lung nodules and need a specific lung biopsy.

Exclusion Criteria

I am severely obese.

I am pregnant or think I might be.

You have a medical device that can be affected by radio waves.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure

Cone-beam CT (Zeego) is used for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 years

What Are the Treatments Tested in This Trial?

Interventions

• Cone Beam CT localization and placement of microcoil

Trial Overview The trial is testing the use of Cone-beam CT to place markers in the lungs to guide surgery for removing small pulmonary nodules during VATS. It's part of a program integrating advanced imaging technologies for surgical precision.

How Is the Trial Designed?

Group I: Lung cancer Experimental Treatment 1 Intervention

Cone Beam CT localization and placement of microcoil is already approved in United States, Canada, European Union for the following indications:

Approved in United States as Percutaneous microcoil localization for:

• Localization of small pulmonary nodules during VATS

Approved in Canada as Cone Beam CT localization and placement of microcoil for:

• Localization of small pulmonary nodules during VATS

Approved in European Union as Fiducial localization for:

• Localization of small pulmonary nodules during VATS

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+

Published Research Related to This Trial

The deeper localization technique for CT-guided microcoil localization of superficial pulmonary nodules achieved a 100% technical success rate, compared to 81.3% for the conventional technique, indicating it is a more reliable method.

While the deeper localization technique did not significantly increase the excised lung volume or the incidence of complications like pneumothorax, it did reduce the risk of coil dislocation, making it a safer option for patients undergoing video-assisted thoracoscopic surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcomes of CT-Guided Deeper Localization Technique for Superficial Pulmonary Nodules. Wu, J., Tian, Y., An, J., et al.[2023]

In a study involving 79 patients with 81 pulmonary nodules, percutaneous transthoracic localization (PTL) using a C-arm cone-beam CT (CBCT) system successfully localized all nodules with a mean distance of only 2.54 mm from the intended markings, demonstrating high accuracy.

The procedure had a manageable complication rate of 17.3%, primarily involving minimal pneumothorax and parenchymal hemorrhage, indicating that PTL can be performed safely with effective outcomes for subsequent surgical excision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Percutaneous transthoracic localization of pulmonary nodules under C-arm cone-beam CT virtual navigation guidance. Kim, TH., Park, CM., Lee, SM., et al.[2022]

The study demonstrated that cone-beam CT-based augmented fluoroscopy (AF) is highly effective for endobronchial navigation, achieving a first-pass success rate of 79% in live swine, indicating its potential for accurate targeting of peripheral lung areas.

No major complications were reported during the in vivo experiments, suggesting that this navigation method is safe for use in clinical settings, especially as it may reduce the need for traditional bronchoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Endobronchial Navigation Guided by Cone-Beam CT-Based Augmented Fluoroscopy without a Bronchoscope: Feasibility Study in Phantom and Swine. de Ruiter, QMB., Karanian, JW., Bakhutashvili, I., et al.[2020]

Cone-beam CT (CBCT) guidance for radiofrequency ablation (RFA) of lung tumors is significantly faster than traditional computed tomography (CT) guidance, regardless of tumor size, as shown in a study involving 40 tumors across 27 patients.

CBCT guidance also resulted in fewer instances of electrode repositioning (27.8% vs. 45.4% for CT) and similar rates of complications, indicating it may be a safer and more efficient option for lung tumor ablation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cone-Beam Computed Tomography (CBCT) Versus CT in Lung Ablation Procedure: Which is Faster? Cazzato, RL., Battistuzzi, JB., Catena, V., et al.[2016]

The optimized CT-guided microcoil localization method for small lung nodules showed a high success rate of 97.1% for localization and 100% for removal during video-assisted thoracoscopic surgery (VATS), indicating its efficacy.

Despite some minor complications, such as pneumothorax and intrapulmonary hematoma, the procedure was deemed safe and effective, making it a promising technique for clinical use in lung surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A Preliminary Study to Evaluate the Efficacy and Safety of A Optimized Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique]. Li, F., Chen, Y., Bian, J., et al.[2020]

Intraoperative percutaneous microcoil localization using C-arm cone-beam CT is a feasible technique that enhances the accuracy of locating small peripheral pulmonary nodules before thoracoscopic surgery.

This method not only improves surgical outcomes by reducing the need for open thoracotomy but also minimizes patient discomfort, leading to a better overall experience for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative Percutaneous Microcoil Localization of Small Peripheral Pulmonary Nodules Using Cone-Beam CT in a Hybrid Operating Room. Lempel, JK., Raymond, DP.[2020]

The study details the technique of using computed tomography-guided microcoil localization for pulmonary nodules before surgery, which aids in precise resection during video-assisted thoracoscopic surgery.

It highlights potential errors in microcoil placement and complications that may arise post-localization, emphasizing the importance of accurate technique to ensure successful surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computed Tomography-guided Pulmonary Nodule Microcoil Localization Technique, Misplacement Errors, and Complications: A Pictorial Essay. Alharbi, SR.[2020]

In a study involving 20 patients, minimally invasive video-assisted thoracic surgery (VATS) was successfully performed to resect small peripheral lung nodules without the need for intraoperative fluoroscopy, demonstrating a reliable approach.

All nodules were accurately localized and resected with negative margins, and there were no major complications reported, indicating the safety of this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Video-Assisted Thoracic Surgery Resection without Intraoperative Fluoroscopy after CT-Guided Microcoil Localization of Peripheral Pulmonary Nodules. Lempel, JK., Raymond, DP., Ahmad, U., et al.[2019]

Endobronchial dye marking using cone-beam computed tomography-derived augmented fluoroscopy (CBCT-AF) for small pulmonary nodules was found to be safe, with no localization-related complications or operative mortality reported in a study of 51 patients with 61 nodules.

The technique demonstrated effective outcomes, as all nodules were successfully marked and resected, with a median postoperative stay of just 4 days, indicating a quick recovery process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time augmented fluoroscopy-guided lung marking for thoracoscopic resection of small pulmonary nodules. Yang, SM., Yu, KL., Lin, KH., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9033024/

Safety and Efficacy of Cone-Beam Computed Tomography ... The purpose of this study was to assess the safety and efficacy of cone-beam computed tomography (CBCT)-guided localization using near-infrared (NIR) marking.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12408194/

C‐Arm Cone Beam CT‐Guided Preoperative Microcoil ... This study evaluates the effectiveness and safety of C‐arm cone beam CT (CBCT)‐guided microcoil localization combined with uniportal ...

3. ajronline.org ajronline.org/doi/10.2214/AJR.19.21175

Intraoperative Percutaneous Microcoil Localization of Small ... In this article, we report our experience using C-arm cone-beam CT to guide intraoperative nodule localizations with microcoils immediately before VATS ...

4. journals.lww.com journals.lww.com/international-journal-of-surgery/fulltext/2025/03000/small_pulmonary_nodule_localization_techniques_in.27.aspx

Small pulmonary nodule localization techniques in the era... Microcoil localization (97-98% success) shows comparable efficacy with lower complication rates. Dye-based methods offer simplicity but can be ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/abs/10.1111/1759-7714.70152

C‐Arm Cone Beam CT‐Guided Preoperative Microcoil ... This study evaluates the effectiveness and safety of C-arm cone beam CT (CBCT)-guided microcoil localization combined with uniportal ...

6. jto.org jto.org/article/S1556-0864(18)31476-X/pdf

MA23.10 Cone-Beam Computed Tomography-Guided ... and 95% confidence limits. Result: A total of 4,938 patients underwent pneumonectomy during the study period, of which 755 (15.3%) were.