Lung Cancer (NSCLC)NCT07257549
Real-Time Non-Invasive Localization for Multiple Lung Nodules
A study testing Manual needle localization and Real-time non-invasive localization in people with Lung Cancer (NSCLC), run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Cancer (NSCLC)
- What is being tested?
- Manual needle localization and Real-time non-invasive localization
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- the maximum diameter of the lesion on CT did not exceed 20 mm;
- at least two pulmonary nodules identified;
- pulmonary nodules showed pure ground-glass opacity (GGO) or mixed GGO on imaging;
- the outer edge of nodules located between 5-20 mm from the nearest pleural surface.
Who cannot join
- nodule location obstructed by the scapula, precluding needle access;
- proximity of the nodule to major blood vessels, defined as within 2 cm;
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated of Guangzhou Medical University
Guangzhou, Guangdong
About this study
Official title: Effectiveness of Real-time Non-invasive Localization for Multiple Lung Nodules: a Pilot, Prospective, Randomized Clinical Trial
This study compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.
Read the detailed description
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a real-time non-invasive localization. The study will be conducted between December 2025 to July 2026, involving 120 patients with multiple lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or real-time non-invasive localization. The primary outcome measure will be the successful resection rate of pulmonary nodules. Secondary outcome measures will include resection margins, changes in operative approach, intraoperative blood loss, operative time, postoperative hospitalization days, the placement of chest tubes, the duration of chest tube placement, and postoperative complications.
- Conditions
- Lung Cancer (NSCLC)
- Being tested
- Manual needle localization, Real-time non-invasive localization
- Keywords
- Preoperative localization, lung nodule, lung cancer, Video-assisted thoracic surgery
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual needle localizationProcedure or surgery
Manual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization. After confirming the needle tip's proximity to the target nodule, indocyanine green (ICG) was injected during deep inspiration to mark the nodule for intraoperative fluorescence imaging. The thoracic surgeon completed resection of the pulmonary nodule based on the area delineated by ICG.
Real-time non-invasive localizationProcedure or surgery
The patient underwent a CT scan prior to surgery. The acquired CT image data was saved in DICOM format and subsequently imported into software for three-dimensional reconstruction of the lung lobes, blood vessels, and bronchi. During the procedure, an assistant created a three-dimensional lung model on a separate monitor, aligning it roughly with the orientation of the deflated lung observed via thoracoscopy. The thoracic surgeon then completed resection of the pulmonary nodule guided by the surgeon's three-dimensional lung model.
| Study group | Role | What they receive |
|---|---|---|
| Non-invasive group | Experimental | Real-time non-invasive localization of multiple pulmonary nodules Receives: Procedure: Real-time non-invasive localization |
| CT-guided group | Active comparator | Manual CT-guided percutaneous needle localization of multiple pulmonary nodules Receives: Procedure: Manual needle localization |
What is being measured
The primary outcome is the main question the study is designed to answer.
The successful resection of all planned target nodules per patient
The primary outcome of this study was the successful resection of all planned target nodules per patient. A lesion was considered successfully resected if the surgical margin was equal to or greater than either the lesion diameter or 2 cm. Generally, after intraoperative resection of the lesion, the margin length was verified by direct measurement on the resected deflated lung specimen. If macroscopic measurement of the surgical margin was challenging, the distance from the nodule to the marker was assessed using intraoperative frozen section analysis. Additionally, any change in surgical approach resulting from unsuccessful nodule localization was considered a failure of lesion resection, regardless of margin size.
Measured: Day of surgery.
Secondary outcomes (8)
Resection margins
Distance from the nodule to the resection margin
Measured: Day of surgery.
Changes in operative approach
During surgery, the planned approach must be changed when the target nodule cannot be completely resected due to various reasons.
Measured: Day of surgery.
Intraoperative blood loss
Hemorrhage during surgery.
Measured: Day of surgery.
Operative time
Total duration of the thoracic surgical procedure, measured in minutes from skin incision to completion of skin closure for the index operation.
Measured: Day of surgery.
Postoperative hospitalization days
The postoperative hospitalization duration refers to the total number of days the patient remains in the hospital from the completion of surgery until discharge.
Measured: Perioperative.
The placement of chest tubes
Determine whether a chest tube needs to be placed based on the patient's condition during surgery.
Measured: Day of surgery.
The duration of chest tube placement
The chest tube placement duration refers to the number of days from the placement of the chest tube after surgery until its removal.
Measured: Perioperative.
Postoperative complications
Postoperative complications refer to any adverse events or symptoms that occur after surgery.
Measured: Perioperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer (NSCLC)Studies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jianxing He, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07257549
- Sponsor's protocol ID
- Non-invasive localization
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Real-time Non-invasive Localization for Multiple Lung Nodules: a Pilot, Prospective, Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07257549
- Acronym / sponsor ID
- Non-invasive localization
- Conditions
- Lung Cancer (NSCLC)
- Keywords
- Preoperative localization, lung nodule, lung cancer, Video-assisted thoracic surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 2 Dec 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 compares real-time non-invasive localization and manual CT-guided needle localization for multiple lung nodules under 20 mm. It primarily aims to evaluate the successful resection rate of pulmonary nodules.
Detailed description
This is a prospective, single-center, non-inferiority clinical study designed to evaluate the effectiveness of a real-time non-invasive localization. The study will be conducted between December 2025 to July 2026, involving 120 patients with multiple lung nodules smaller than 20 mm in diameter. Participants will be randomly assigned to receive either CT-guided manual needle localization or real-time non-invasive localization. The primary outcome measure will be the successful resection rate of pulmonary nodules. Secondary outcome measures will include resection margins, changes in operative approach, intraoperative blood loss, operative time, postoperative hospitalization days, the placement of chest tubes, the duration of chest tube placement, and postoperative complications.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-invasive group | Experimental | Procedure: Real-time non-invasive localizationReal-time non-invasive localization of multiple pulmonary nodules |
| CT-guided group | Active comparator | Procedure: Manual needle localizationManual CT-guided percutaneous needle localization of multiple pulmonary nodules |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- the maximum diameter of the lesion on CT did not exceed 20 mm;
- at least two pulmonary nodules identified;
- pulmonary nodules showed pure ground-glass opacity (GGO) or mixed GGO on imaging;
- the outer edge of nodules located between 5-20 mm from the nearest pleural surface.
Key exclusion criteria (2 listed)
- nodule location obstructed by the scapula, precluding needle access;
- proximity of the nodule to major blood vessels, defined as within 2 cm;
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 |
|---|---|---|
| Manual needle localizationManual needle localization involves the traditional technique of percutaneous localization of pulmonary nodules under CT guidance. The procedure is performed by the physician manually guiding the needle based on real-time CT imaging. The physician adjusts the needle position based on visual cues from the CT scan, which may require multiple attempts for accurate localization. After confirming the needle tip's proximity to the target nodule, indocyanine green (ICG) was injected during deep inspiration to mark the nodule for intraoperative fluorescence imaging. The thoracic surgeon completed resection of the pulmonary nodule based on the area delineated by ICG. | Procedure or surgery | CT-guided group |
| Real-time non-invasive localizationThe patient underwent a CT scan prior to surgery. The acquired CT image data was saved in DICOM format and subsequently imported into software for three-dimensional reconstruction of the lung lobes, blood vessels, and bronchi. During the procedure, an assistant created a three-dimensional lung model on a separate monitor, aligning it roughly with the orientation of the deflated lung observed via thoracoscopy. The thoracic surgeon then completed resection of the pulmonary nodule guided by the surgeon's three-dimensional lung model. | Procedure or surgery | Non-invasive group |
Primary outcome
The successful resection of all planned target nodules per patient
Time frame: Day of surgery.
The primary outcome of this study was the successful resection of all planned target nodules per patient. A lesion was considered successfully resected if the surgical margin was equal to or greater than either the lesion diameter or 2 cm. Generally, after intraoperative resection of the lesion, the margin length was verified by direct measurement on the resected deflated lung specimen. If macroscopic measurement of the surgical margin was challenging, the distance from the nodule to the marker was assessed using intraoperative frozen section analysis. Additionally, any change in surgical approach resulting from unsuccessful nodule localization was considered a failure of lesion resection, regardless of margin size.
8 secondary outcomes
Resection margins
Time frame: Day of surgery.
Changes in operative approach
Time frame: Day of surgery.
Intraoperative blood loss
Time frame: Day of surgery.
Operative time
Time frame: Day of surgery.
Postoperative hospitalization days
Time frame: Perioperative.
The placement of chest tubes
Time frame: Day of surgery.
The duration of chest tube placement
Time frame: Perioperative.
Postoperative complications
Time frame: Perioperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual needle localization and Real-time non-invasive localization in people with Lung Cancer (NSCLC), run by The First Affiliated Hospital of 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 22 Oct 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The successful resection of all planned target nodules per patient (time frame: Day of surgery.). 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 22 Oct 2026.