Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS

NCT07177924 | Not Yet Recruiting

• 1 other identifier: 2025YJZ92
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is a single-center, prospective, single-arm clinical study conducted at Beijing Cancer Hospital to evaluate the effectiveness, safety, and learning curve of preoperative indocyanine green (ICG) dye marking mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) for small pulmonary nodules that are difficult to locate during video-assisted thoracic surgery (VATS) sublobectomy. Eligible patients will undergo RAB localization immediately followed by VATS in the same operative session. The primary endpoints include the success rate of localization, effective localization, and VATS sublobar resection. Secondary endpoints include navigation success rate, operation times, reaching depth, complication rates, and health economic outcomes. The learning curve will be analyzed using the cumulative sum (CUSUM) method. A total of 50 patients will be enrolled and followed up for 14 days postoperatively.

Conditions

Small Pulmonary Nodules; Pulmonary Nodule Localization; Lung Cancer (Suspected or Confirmed); Video-assisted Thoracoscopic Surgery (VATS)

Keywords

Robotic Assisted Bronchoscopy; Monarch Platform; Lung Nodule Localization; Video-Assisted Thoracoscopic Surgery (VATS); Pulmonary Nodules; Lung Cancer Surgery

Outcome Measures

Primary Outcomes (3)

• Success rate of localization procedure

  Calculated as (number of successful localization procedures ÷ total localization procedures) × 100%. Success is defined as ICG dye successfully injected at planned target site as confirmed by CBCT. Unit of Measure: participants (%).

  Periprocedural( localization procedure)

• Success rate of effective localization

  Calculated as \[(number of successful localization procedures - number unrecognized in operative field) ÷ total localization procedures\] × 100%. Effective localization is defined as visible ICG staining on pleura during VATS. Unit of Measure: participants (%).

  Perioperative (during VATS)

• Success rate of VATS sub-lobar resection

  Calculated as (number of successful VATS resections ÷ total localization procedures) × 100%. Successful VATS resection is defined as resection containing the complete lesion and the dye together. Unit of Measure: participants (%).

  Perioperative (during VATS)

Secondary Outcomes (3)

• Learning curve for localization

  Through study completion, up to 8 months

• Bronchoscopy-related complication rate

  From end of bronchoscopy through Postoperative Day 14.

• Health economic outcomes

  During index hospitalization

Study Arms (1)

Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy

EXPERIMENTAL

All participants will undergo preoperative localization of small pulmonary nodules using indocyanine green (ICG) mixed with iodinated contrast agent under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) guidance, performed by a single surgeon without prior RAB localization experience. Immediately after localization, patients will undergo video-assisted thoracoscopic surgery (VATS) sublobectomy (wedge resection or segmentectomy).

Procedure: Monarch RAB with CBCT-guided ICG Dye Marking

Interventions

Monarch RAB with CBCT-guided ICG Dye Marking PROCEDURE

Under general anesthesia, the Monarch RAB platform is used to navigate to the target bronchus. With CBCT confirmation, 0.25 ml of ICG (0.2 mg/ml) mixed with 0.25 ml iodinated contrast is injected within 1 cm of the nodule. The dye marking is identified intraoperatively with near-infrared light to guide VATS sublobectomy.

Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-80 years
• Clinically indicated sub-lobar resection
• Tolerates general anesthesia
• Single/multiple small nodules \<20 mm in peripheral lung field
• Nodules difficult to locate intraoperatively by inspection/palpation

You may not qualify if:

• Contraindications to bronchoscopy/anesthesia
• Coagulopathy or bleeding tendency
• Implanted devices interfering with navigation
• Allergy to ICG or iodinated contrast
• Pregnant/lactating women
• Intraoperative findings not suitable for procedure

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

MeSH Terms

Conditions

Lung Neoplasms; Multiple Pulmonary Nodules

Condition Hierarchy (Ancestors)

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

Study Officials

• Shaohua Ma

  Peking University Cancer Hospital & Institute, Beijing 100142, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bingyang Huang

CONTACT

+8613161541915; bingyanghuang@outlook.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-center, prospective, single-arm interventional study in which all enrolled patients with small pulmonary nodules difficult to localize during VATS will undergo preoperative indocyanine green (ICG) mixed with iodinated contrast dye marking under Monarch Robotic Assisted Bronchoscopy (RAB) with Cone-Beam CT (CBCT) guidance, immediately followed by VATS sublobectomy in the same operative session. The localization procedure is performed by a single surgeon without prior RAB localization experience to evaluate the learning curve.

Study Record Dates

• First Submitted: August 27, 2025
• First Posted: September 17, 2025
• Study Start: October 10, 2025
• Primary Completion: April 30, 2026
• Study Completion (Estimated): May 30, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share