Small Pulmonary NodulesREALMNCT07177924
Monarch Robotic Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS
A study testing Monarch RAB with CBCT-guided ICG Dye Marking in people with Small Pulmonary Nodules and Pulmonary Nodule Localization, run by Peking University Cancer Hospital & Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Small Pulmonary Nodules, Pulmonary Nodule Localization, Lung Cancer (Suspected or Confirmed)
- What is being tested?
- Monarch RAB with CBCT-guided ICG Dye Marking
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 10 Oct 2025to 30 May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
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)
- Being tested
- Monarch RAB with CBCT-guided ICG Dye Marking
- Keywords
- Robotic Assisted Bronchoscopy, Monarch Platform, Lung Nodule Localization, Video-Assisted Thoracoscopic Surgery (VATS), Pulmonary Nodules, Lung Cancer Surgery
- Medical subject headings
- Lung Neoplasms, Multiple Pulmonary Nodules
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monarch RAB with CBCT-guided ICG Dye MarkingProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Procedure: Monarch RAB with CBCT-guided ICG Dye Marking |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 (%).
Measured: 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 (%).
Measured: 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 (%).
Measured: Perioperative (during VATS)
Secondary outcomes (3)
Learning curve for localization
Number of cases required for surgeon to achieve proficiency using cumulative sum (CUSUM) method based on OT1 and localization success rate.Unit of Measure: case number.
Measured: Through study completion, up to 8 months
Bronchoscopy-related complication rate
Incidence of pneumothorax, bleeding, and respiratory failure related to bronchoscopy, graded according to CTCAE. participants (%).
Measured: From end of bronchoscopy through Postoperative Day 14.
Health economic outcomes
Includes postoperative hospital stay, total hospitalization cost, complication treatment cost, anesthesia cost, and localization procedure cost. Unit of Measure: CNY.
Measured: During index hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start10 Oct 2025 (estimated)
- Primary completion30 Apr 2026 (estimated)
- Study completion30 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small Pulmonary NodulesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Shaohua Ma, Principal investigator, Peking University Cancer Hospital & Institute, Beijing 100142, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177924
- Sponsor's protocol ID
- 2025YJZ92
- Acronym
- REALM
- Status last verified
- Aug 2025
- First submitted
- 27 Aug 2025
- Last updated
- 17 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness, Safety and Learning Curve of Monarch Robotic Assisted Bronchoscopy for Lung Nodule ICG Dye Marking Before VATS Sublobectomy
- ClinicalTrials.gov ID
- NCT07177924
- Acronym / sponsor ID
- REALM / 2025YJZ92
- 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
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Study start
- 10 Oct 2025 (estimated)
- Primary completion
- 30 Apr 2026 (estimated)
- Study completion
- 30 May 2026 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy | Experimental | Procedure: Monarch RAB with CBCT-guided ICG Dye MarkingAll 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- Contraindications to bronchoscopy/anesthesia
- Coagulopathy or bleeding tendency
- Implanted devices interfering with navigation
- Allergy to ICG or iodinated contrast
- Pregnant/lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monarch RAB with CBCT-guided ICG Dye MarkingUnder 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. | Procedure or surgery | Experimental: Monarch RAB + CBCT-guided ICG Localization + VATS Sublobectomy |
Primary outcome
Success rate of localization procedure
Time frame: Periprocedural( 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 (%).
Success rate of effective localization
Time frame: Perioperative (during VATS)
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 (%).
Success rate of VATS sub-lobar resection
Time frame: Perioperative (during VATS)
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 (%).
3 secondary outcomes
Learning curve for localization
Time frame: Through study completion, up to 8 months
Bronchoscopy-related complication rate
Time frame: From end of bronchoscopy through Postoperative Day 14.
Health economic outcomes
Time frame: During index hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Shaohua Ma principal investigator
Peking University Cancer Hospital & Institute, Beijing 100142, China
Questions about this trial
What is this clinical trial studying?
A study testing Monarch RAB with CBCT-guided ICG Dye Marking in people with Small Pulmonary Nodules and Pulmonary Nodule Localization, run by Peking University Cancer Hospital & Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bingyang Huang (+8613161541915, bingyanghuang@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of localization procedure (time frame: Periprocedural( localization procedure)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2025.