Peripheral Pulmonary LesionNCT07004946
Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions
An observational study of Peripheral Pulmonary Lesion, run by Guangzhou Medical University at 1 site in China.
Trial summary
This study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Peripheral Pulmonary Lesion
- How many people
- 286 participants
- Where
- 1 siteChina
- Study dates
- 31 May 2025to 31 Dec 2026
- Phase
- Observational
- 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
Study population: 1. All subjects have completed CelTouch examination 2. Each subject has obtained a clear histological diagnosis or clinical follow-up diagnosis for 6 months
Who may be able to join
- Aged ≥18 years, with lung lesions detected by chest CT and scheduled for lung biopsy;
- Preoperative CT indicates the presence of a bronchus leading to the lesion to be biopsied;
- Able to understand and willing to sign a written informed consent form. -
Who cannot join
- Those with contraindications to general anesthesia or bronchoscopy;
- Patients with uncorrectable coagulation disorders;
- Unable to discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
- Patients with severe liver or kidney dysfunction, cardiovascular and cerebrovascular diseases, mental illnesses, etc.;
- Pregnant or lactating patients;
- Those without a clear histological or clinical diagnosis;
- Subjects deemed unsuitable by the investigator. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong 510163
Guangzhou, Guangdong, 510100
Shiyue Li, 02081566640, lishiyue@gird.cn
About this study
This study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung lesions will be validated through multicenter clinical research; and a CLE atlas for peripheral lung lesions will be constructed to establish a visual classification diagnostic system for peripheral lung lesions.
(1) Comparative Study of In Vivo CLE Images and Pathological Images in the Diagnosis of Peripheral Lung Lesions
- Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions.
- A diagnostic team composed of 1 bronchoscopy expert, 1 pathology expert, and 2 CLE experts will correlate in vivo and ex vivo CLE images of lung lesions with corresponding pathological images, analyze CLE image characteristics of benign and malignant lung lesions, and establish CLE diagnostic criteria for benign and malignant lung lesions. (2) Validation Study of the Diagnostic Performance of Confocal Laser Endomicroscopy in Peripheral Lung Lesions
- Multicenter screening of corresponding subjects according to inclusion and exclusion criteria, collection of corresponding videos and images during surgery, and recording of observed characteristic images based on pre-established diagnostic characteristics and criteria.
- The diagnostic team and sub-center representatives (5 in total) will perform offline interpretation of the collected images and videos, and evaluate the diagnostic performance of CLE in peripheral lung lesions using the accurate diagnostic results obtained from postoperative histopathology or 6-month clinical follow-up as the standard.
- Establishment of a CLE Atlas and Classification System for Lung Lesions (1) Collect large-scale in vivo and ex vivo CLE images and pathological images of clearly diagnosed lung lesions from multiple centers. (2) Select typical in vivo and ex vivo CLE images of lung lesions with the same pathological type and corresponding pathological images, and jointly describe the CLE image diagnostic characteristics by pathology experts and CLE experts to establish a CLE atlas for peripheral lung lesions. (3) Establish a visual classification system for the internal structure of peripheral lung lesions based on the special signs in CLE images of lung lesions.
- Conditions
- Peripheral Pulmonary Lesion
- Keywords
- peripheral pulmonary lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Confocal laser endomicroscopy group | Utilize confocal laser endomicroscopy for the examination of peripheral lung lesions in patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic yield
diagnostic yield=(The number of cases with a definitive diagnosis / The total number of cases enrolled in the trial) × 100%
Measured: 6 months after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2025
- Study start31 May 2025 (estimated)
- Primary completion1 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Pulmonary LesionStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 286 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Shiyue, Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07004946
- Sponsor's protocol ID
- CelTouch clinical trial
- Status last verified
- May 2025
- First submitted
- 26 May 2025
- Last updated
- 4 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wijmans L, Yared J, de Bruin DM, Meijer SL, Baas P, Bonta PI, Annema JT. Needle-based confocal laser endomicroscopy for real-time diagnosing and staging of lung cancer. Eur Respir J. 2019 Jun 20;53(6):1801520. doi: 10.1183/13993003.01520-2018. Print 2019 Jun.
PubMed 31023849
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Value of Confocal Laser Endomicroscopy (CelTouch) for Peripheral Lung Lesions
- ClinicalTrials.gov ID
- NCT07004946
- Acronym / sponsor ID
- CelTouch clinical trial
- Conditions
- Peripheral Pulmonary Lesion
- Keywords
- peripheral pulmonary lesion
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 286 participants (estimated)
- Lead sponsor
- Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 31 May 2025 (estimated)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Jun 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 study uses CelTouch to explore patients with lung lesions scheduled for lung biopsy. By comparing with preclinical CLE images and pathological images, CLE diagnostic criteria for benign and malignant lung lesions under the microscope will be established; the performance of CLE in diagnosing peripheral lung lesions will be validated through multicenter clinical research; and a CLE atlas for peripheral lung lesions will be constructed to establish a visual classification diagnostic system for peripheral lung lesions.
(1) Comparative Study of In Vivo CLE Images and Pathological Images in the Diagnosis of Peripheral Lung Lesions
- Collect CLE images and histopathological sections of clearly diagnosed peripheral lung lesions.
- A diagnostic team composed of 1 bronchoscopy expert, 1 pathology expert, and 2 CLE experts will correlate in vivo and ex vivo CLE images of lung lesions with corresponding pathological images, analyze CLE image characteristics of benign and malignant lung lesions, and establish CLE diagnostic criteria for benign and malignant lung lesions. (2) Validation Study of the Diagnostic Performance of Confocal Laser Endomicroscopy in Peripheral Lung Lesions
- Multicenter screening of corresponding subjects according to inclusion and exclusion criteria, collection of corresponding videos and images during surgery, and recording of observed characteristic images based on pre-established diagnostic characteristics and criteria.
- The diagnostic team and sub-center representatives (5 in total) will perform offline interpretation of the collected images and videos, and evaluate the diagnostic performance of CLE in peripheral lung lesions using the accurate diagnostic results obtained from postoperative histopathology or 6-month clinical follow-up as the standard.
- Establishment of a CLE Atlas and Classification System for Lung Lesions (1) Collect large-scale in vivo and ex vivo CLE images and pathological images of clearly diagnosed lung lesions from multiple centers. (2) Select typical in vivo and ex vivo CLE images of lung lesions with the same pathological type and corresponding pathological images, and jointly describe the CLE image diagnostic characteristics by pathology experts and CLE experts to establish a CLE atlas for peripheral lung lesions. (3) Establish a visual classification system for the internal structure of peripheral lung lesions based on the special signs in CLE images of lung lesions.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Confocal laser endomicroscopy group | – | –Utilize confocal laser endomicroscopy for the examination of peripheral lung lesions in patients. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. All subjects have completed CelTouch examination 2. Each subject has obtained a clear histological diagnosis or clinical follow-up diagnosis for 6 months
Key inclusion criteria (3 listed)
- Aged ≥18 years, with lung lesions detected by chest CT and scheduled for lung biopsy;
- Preoperative CT indicates the presence of a bronchus leading to the lesion to be biopsied;
- Able to understand and willing to sign a written informed consent form. -
Key exclusion criteria (7 listed)
- Those with contraindications to general anesthesia or bronchoscopy;
- Patients with uncorrectable coagulation disorders;
- Unable to discontinue therapeutic anticoagulants within an appropriate time interval before surgery;
- Patients with severe liver or kidney dysfunction, cardiovascular and cerebrovascular diseases, mental illnesses, etc.;
- Pregnant or lactating patients;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diagnostic yield
Time frame: 6 months after procedure
diagnostic yield=(The number of cases with a definitive diagnosis / The total number of cases enrolled in the trial) × 100%
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 4 Jun 2025.
- Background: PubMed 31023849Wijmans L, Yared J, de Bruin DM, Meijer SL, Baas P, Bonta PI, Annema JT. Needle-based confocal laser endomicroscopy for real-time diagnosing and staging of lung cancer. Eur Respir J. 2019 Jun 20;53(6):1801520. doi: 10.1183/13993003.01520-2018. Print 2019 Jun.
- Individual participant dataSharing planned: No
Related trials for Peripheral Pulmonary Lesion
Recruiting
Robotic Systems Evaluation for Peripheral Pulmonary Lesions (RISE Trial)
Lung; Node
RecruitingPhase 2
OPTIMISE Lung SABR
Non Small Cell Lung Cancer
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruitingObservational study
Clinical Utility of Needle-Based Confocal Laser Endomicroscopy for Peripheral Pulmonary Lesions
Peripheral Pulmonary Lesions
Not yet recruiting
Iriscope for the Diagnosis of Peripheral Pulmonary Lesions: a Multicentre Randomised Controlled Trial
Lung Nodule, Solitary, Lung Nodule
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Pulmonary Lesion, run by Guangzhou Medical University 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 3 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: looking for participants now, as of the sponsor's last update on 4 Jun 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 Shiyue Li (02081566640, lishiyue@gird.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic yield (time frame: 6 months after procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07004946, which also lists 1 linked publication.
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 4 Jun 2025.