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

Trial Summary

What is the purpose of this trial?

The Guided Therapeutics (GTx) program at the University Health Network is a network of clinicians, scientists, and engineers focused on the development and translation of image-guided technologies focused on minimally-invasive, adaptive therapies. Technologies developed within the GTx program include a portable intra-operative cone-beam CT (in collaboration with Siemens) that has been evaluated in clinical trials for head and neck surgery. The intraoperative imaging has been integrated with tracking and navigational tools and optical imaging to provide a general "surgical dashboard" that is used to improve the accuracy of surgical resection. A recent addition to the GTx program is the development of the GTx OR, located within the general operating room of the Toronto General Hospital. The GTx OR houses 2 complimentary advance technologies: the Siemens Zeego and the Siemens Somotom Flash CT. The dual-energy Somatom Flash provides a "gold-standard" in CT imaging, while the Zeego provides excellent 3D Cone-beam CT with robotic placement for flexible integration within the operating environment. Together, the integration of these 2 components into a single OR enables critical evaluation of the limits of CT imaging technology for surgical guidance. This study will be conducted using solely the Cone-beam CT (Zeego) for percutaneous placement and localization of markers for resection of small pulmonary nodules during VATS.

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 data supports the effectiveness of the treatment Cone Beam CT Guided Localization for Lung Cancer?

Research shows that using cone-beam CT for guiding the placement of microcoils in lung cancer surgery helps accurately locate small lung nodules, making surgery safer and more comfortable for patients. This technique is effective in ensuring precise targeting, which can improve surgical outcomes. ^{1 2 3 4 5}

Is Cone-Beam CT Guided Localization for Lung Cancer safe?

Research shows that Cone-Beam CT Guided Localization, including techniques like microcoil placement, is generally safe for marking small lung nodules. Studies report successful localization with minimal patient discomfort and no major complications. ^{1 2 6 7 8}

How is the Cone-Beam CT Guided Localization treatment for lung cancer different from other treatments?

This treatment uses cone-beam CT (a type of imaging technology) to guide the precise placement of a microcoil (a small wire) in the lung, which helps in accurately locating small lung nodules before surgery. This approach is unique because it enhances the accuracy of nodule localization while minimizing patient discomfort compared to traditional methods. ^{1 2 4 5 9}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

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

2. Turkey pubmed.ncbi.nlm.nih.gov

Percutaneous transthoracic localization of pulmonary nodules under C-arm cone-beam CT virtual navigation guidance. [2022]

3. China 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]. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

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

5. United States pubmed.ncbi.nlm.nih.gov

Endobronchial Navigation Guided by Cone-Beam CT-Based Augmented Fluoroscopy without a Bronchoscope: Feasibility Study in Phantom and Swine. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Video-Assisted Thoracic Surgery Resection without Intraoperative Fluoroscopy after CT-Guided Microcoil Localization of Peripheral Pulmonary Nodules. [2019]

7. Germany pubmed.ncbi.nlm.nih.gov

Outcomes of CT-Guided Deeper Localization Technique for Superficial Pulmonary Nodules. [2023]

8. Germany pubmed.ncbi.nlm.nih.gov

Real-time augmented fluoroscopy-guided lung marking for thoracoscopic resection of small pulmonary nodules. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Cone-Beam Computed Tomography (CBCT) Versus CT in Lung Ablation Procedure: Which is Faster? [2016]