Lung Ground-Glass OpacityNCT06910046
GGO-dominant PPLs Diagnosis Using CLE and ssRAB-guided Cryobiopsy
A study testing CLE and ssRAB-guided cryobiopsy in people with Lung Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
Trial summary
The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Ground-Glass Opacity
- What is being tested?
- CLE and ssRAB-guided cryobiopsy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- Apr 2025to Apr 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age≥18 years;
- Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
- Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
- Patients who have good compliance and sign informed consent.
Who cannot join
- Diffuse GGO, suspected of benign or infectious lesions;
- Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
- Patients with contraindications of bronchoscopy;
- Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
- Pregnant or lactating women;
- Patients with known allergy for fluorescein;
- The investigators believe that patient has other conditions that are not suitable for the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study
The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.
Read the detailed description
This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.
- Conditions
- Lung Ground-Glass Opacity
- Being tested
- CLE and ssRAB-guided cryobiopsy
- Keywords
- ground-glass opacity, robotic-assisted bronchoscopy, confocal laser endomicroscopy, cryobiopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLE and ssRAB-guided cryobiopsyDiagnostic test
All procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy.
| Study group | Role | What they receive |
|---|---|---|
| Patients with GGO-dominant peripheral pulmonary lesions | Experimental | Approximately 119 patients with GGO-dominant PPLs who meet the inclusion and exclusion criteria will be prospectively enrolled. CLE and ssRAB-guided cryobiopsy will be performed to diagnose the lesion. Receives: Diagnostic Test: CLE and ssRAB-guided cryobiopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.
Measured: 1 year
Secondary outcomes (5)
Diagnostic accuracy
Diagnostic accuracy is calculated according to the standard definition using the classical 2*2 table.
Measured: 1 year
Diagnostic sensitivity
Diagnostic sensitivity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.
Measured: 1 year
Diagnostic specificity
Diagnostic specificity is calculated according to the standard definition using the classical 2*2 table. Malignancy is considered as positive.
Measured: 1 year
CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.
The CLE interpretation criteria for different kinds of GGO-dominant PPLs and the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the proposed criteria in differentiating benign from malignant lesions.
Measured: 1 year
Complication rate
The complications refer to the total of device or procedure related adverse events during or within 1 month after the operation.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2025
- Study startApr 2025 (estimated)
- Primary completionApr 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Ground-Glass OpacityStudies of the same condition, open and under way.
- More trials run by Shanghai Chest HospitalThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 119 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayuan Sun, Shanghai Chest Hospital
- Investigators
- Jiayuan Sun, MD, PhD, Study director, Shanghai Chest Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06910046
- Sponsor's protocol ID
- IS25061
- Status last verified
- Apr 2025
- First submitted
- 26 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ground-glass Opacity-dominant Peripheral Pulmonary Lesions Diagnosis Using Confocal Laser Endomicroscopy and Shape-sensing Robotic-assisted Bronchoscopy Guided Cryobiopsy: GLASS-CLEAR Study
- ClinicalTrials.gov ID
- NCT06910046
- Acronym / sponsor ID
- IS25061
- Conditions
- Lung Ground-Glass Opacity
- Keywords
- ground-glass opacity, robotic-assisted bronchoscopy, confocal laser endomicroscopy, cryobiopsy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 119 participants (estimated)
- Lead sponsor
- Shanghai Chest HospitalUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 4 Apr 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.
The purpose of the study is to evaluate the diagnostic performance and safety of cryobiopsy for ground-glass opacity (GGO)-dominant peripheral pulmonary lesions (PPLs) under the guidance of shape-sensing robotic-assisted bronchoscopy (ssRAB) combined with confocal laser endomicroscopy (CLE). Additionally, the study aims to establish CLE interpretation criteria for GGO-dominant PPLs based on histopathological characteristics and validate the proposed criteria.
Detailed description
This is a single-arm, single-center, and prospective study. Approximately 119 patients with GGO-dominant PPLs will be enrolled to undergo CLE and ssRAB-guided cryobiopsy for the diagnosis of lesions. During the procedure, CLE will be used to examine the lesion. The primary endpoint is the diagnostic yield of the procedure. The secondary endpoints include the diagnostic accuracy, sensitivity, specificity, positive predictive value, and negative predictive value of the procedure, CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions, and the complication rate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with GGO-dominant peripheral pulmonary lesions | Experimental | Diagnostic Test: CLE and ssRAB-guided cryobiopsyApproximately 119 patients with GGO-dominant PPLs who meet the inclusion and exclusion criteria will be prospectively enrolled. CLE and ssRAB-guided cryobiopsy will be performed to diagnose the lesion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age≥18 years;
- Thin-slice chest CT showing GGO-dominant peripheral pulmonary lesions (diameter≥8mm, GGO component≥50%);
- Suspected pulmonary malignant tumor which requires transbronchial lung biopsy for diagnosis;
- Patients who have good compliance and sign informed consent.
Key exclusion criteria (7 listed)
- Diffuse GGO, suspected of benign or infectious lesions;
- Preoperative imaging showing the target biopsy lesion adjacent to medium or large blood vessels;
- Patients with contraindications of bronchoscopy;
- Presence of concomitant endobronchial lesion during the bronchoscopy procedure;
- Pregnant or 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 |
|---|---|---|
| CLE and ssRAB-guided cryobiopsyAll procedures are performed under general anesthesia with endotracheal intubation and mechanical ventilation. A conventional flexible bronchoscope is used to examine the subject's airway and clear the secretion. After the registration procedure is completed, the catheter of the ssRAB system is navigated to the target lesion. Cone beam computed tomography (CBCT) is used to confirm whether the target lesion has been reached. After that, an appropriate CLE probe is inserted. Right before CLE imaging, 2.5 ml of 10% fluorescein sodium is administered intravenously. CLE is then used to examine the target lesion. Based on real-time CLE imaging, the optimal biopsy location is identified and localized on the fluoroscopy. After CLE imaging, the CLE probe is retracted, followed by cryobiopsy at the same location under fluoroscopy guidance. Rapid on-site evaluation is available during the procedure to assess sample adequacy. | Diagnostic test | Patients with GGO-dominant peripheral pulmonary lesions |
Primary outcome
Diagnostic yield
Time frame: 1 year
Diagnostic yield is defined as the number of diagnostic lesions divided by the total number of lesions.
5 secondary outcomes
Diagnostic accuracy
Time frame: 1 year
Diagnostic sensitivity
Time frame: 1 year
Diagnostic specificity
Time frame: 1 year
CLE interpretation criteria for GGO-dominant PPLs and its diagnostic efficacy in differentiating benign from malignant lesions.
Time frame: 1 year
Complication rate
Time frame: 1 month
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 6 Apr 2025.
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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.
Jiayuan Sun, MD, PhD study director
Shanghai Chest Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLE and ssRAB-guided cryobiopsy in people with Lung Ground-Glass Opacity, run by Shanghai Chest Hospital at 1 site in China.
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 4 inclusion and 7 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 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Jiayuan Sun, MD, PhD (86-021-22200000 ext. 1511, jysun1976@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 1 year). 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 6 Apr 2025.