Non Small Cell Lung CancerPET-Rad-NSCLCNCT07449858
18F-FDG PET/CT Radiomics Models for Precision Diagnosis and Prognosis in NSCLC
An observational study of Non Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites in China.
Trial summary
This multicenter retrospective study aims to investigate the value of 18F-FDG PET/CT radiomics features in the preoperative precision staging, pathological typing, gene mutation status prediction, and prognostic risk stratification of patients with Non-Small Cell Lung Cancer (NSCLC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non Small Cell Lung Cancer
- How many people
- 500 participants
- Where
- 4 sitesChina
- Study dates
- 1 Jul 2025to 31 Dec 2027
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with pathologically confirmed Non-Small Cell Lung Cancer (NSCLC) who underwent standard preoperative whole-body 18F-FDG PET/CT examinations at The Second Affiliated Hospital of Zhejiang University School of Medicine and other participating tertiary hospitals.
Who may be able to join
- Age >= 18 years.
- Underwent standard whole-body 18F-FDG PET/CT scan within 30 days before surgery.
- Histopathologically confirmed Non-Small Cell Lung Cancer (NSCLC) with clear histological subtyping and complete postoperative TNM staging.
- Primary tumor SUVmax > 2.5 and maximum diameter > 1.0 cm on CT.
- Complete clinical, pathological, and imaging data available.
- (For Gene Sub-study) Known EGFR gene mutation status.
- (For Prognosis Sub-study) Complete follow-up data available (minimum 12 months or until endpoint event).
Who cannot join
- History of other malignancies.
- Received any anti-tumor treatment (chemotherapy, radiotherapy, targeted therapy, immunotherapy) prior to PET/CT.
- Severe image artifacts or indistinct tumor boundaries affecting ROI delineation.
- Missing key clinical or pathological data.
- Baseline PET/CT evaluated recurrent or metastatic tumors instead of primary NSCLC.
- Extremely short life expectancy due to severe comorbidities.
Trial locations and contacts
4 sites in 1 country.
China4 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Guangdong Second Provincial General Hospital
Guangzhou, Guangdong, 510317
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
The First Hospital of China Medical University
Shenyang, Liaoning, 110001
About this study
Official title: Construction and Validation of Precision Diagnosis and Treatment Models for Non-Small Cell Lung Cancer (NSCLC) Based on 18F-FDG PET/CT Radiomics: A Multicenter Retrospective Clinical Study
This multicenter retrospective study aims to investigate the value of 18F-FDG PET/CT radiomics features in the preoperative precision staging, pathological typing, gene mutation status prediction, and prognostic risk stratification of patients with Non-Small Cell Lung Cancer (NSCLC). The study involves constructing and validating machine learning models to provide imaging-based evidence for individualized precision clinical decision-making.
Read the detailed description
The study consists of three main parts based on a multicenter retrospective cohort:
Staging and Typing: Developing radiomics models to distinguish histological subtypes (Adenocarcinoma vs. Squamous Cell Carcinoma) and predict TNM staging preoperatively.
Gene Mutation Prediction: Analyzing radiomics signatures to predict EGFR mutation status (Mutant vs. Wild-type) non-invasively.
Prognostic Assessment: Evaluating the prognostic value of radiomics features by analyzing their association with Disease-Free Survival (DFS) and Overall Survival (OS).
High-throughput radiomics features will be extracted from standardized PET/CT images and analyzed using machine learning algorithms.
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- 18F-FDG PET/CT, Radiomics, Artificial Intelligence, EGFR Mutation, Prognosis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
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 |
|---|---|---|
| NSCLC Cohort | Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic Performance for TNM Staging and Histological Subtyping
Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC), Sensitivity, and Specificity of the radiomics model in predicting T-stage, N-stage, and histological subtypes (ADC vs. SCC).
Measured: Baseline
Predictive Accuracy for EGFR Mutation Status
Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.
Measured: Baseline
Prognostic Value
Evaluation of Disease-Free Survival (DFS) and Overall Survival (OS). DFS is defined as time to recurrence or death. OS is defined as time to death from any cause.
Measured: From date of surgery up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start1 Jul 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- First Hospital of China Medical University, West China Hospital, Guangdong Second Provincial General Hospital
- Responsible party
- Sponsor
- Investigators
- Xiaohui Zhang, Principal investigator, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449858
- Sponsor's protocol ID
- 2025-0690
- Acronym
- PET-Rad-NSCLC
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Validation of Precision Diagnosis and Treatment Models for Non-Small Cell Lung Cancer (NSCLC) Based on 18F-FDG PET/CT Radiomics: A Multicenter Retrospective Clinical Study
- ClinicalTrials.gov ID
- NCT07449858
- Acronym / sponsor ID
- PET-Rad-NSCLC / 2025-0690
- Conditions
- Non Small Cell Lung Cancer
- Keywords
- 18F-FDG PET/CT, Radiomics, Artificial Intelligence, EGFR Mutation, Prognosis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- First Hospital of China Medical University, West China Hospital, Guangdong Second Provincial General Hospital
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Mar 2026 (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 multicenter retrospective study aims to investigate the value of 18F-FDG PET/CT radiomics features in the preoperative precision staging, pathological typing, gene mutation status prediction, and prognostic risk stratification of patients with Non-Small Cell Lung Cancer (NSCLC). The study involves constructing and validating machine learning models to provide imaging-based evidence for individualized precision clinical decision-making.
Detailed description
The study consists of three main parts based on a multicenter retrospective cohort:
Staging and Typing: Developing radiomics models to distinguish histological subtypes (Adenocarcinoma vs. Squamous Cell Carcinoma) and predict TNM staging preoperatively.
Gene Mutation Prediction: Analyzing radiomics signatures to predict EGFR mutation status (Mutant vs. Wild-type) non-invasively.
Prognostic Assessment: Evaluating the prognostic value of radiomics features by analyzing their association with Disease-Free Survival (DFS) and Overall Survival (OS).
High-throughput radiomics features will be extracted from standardized PET/CT images and analyzed using machine learning algorithms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NSCLC Cohort | – | –Patients with pathologically confirmed NSCLC who underwent standard preoperative 18F-FDG PET/CT examination. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed Non-Small Cell Lung Cancer (NSCLC) who underwent standard preoperative whole-body 18F-FDG PET/CT examinations at The Second Affiliated Hospital of Zhejiang University School of Medicine and other participating tertiary hospitals.
Key inclusion criteria (7 listed)
- Age >= 18 years.
- Underwent standard whole-body 18F-FDG PET/CT scan within 30 days before surgery.
- Histopathologically confirmed Non-Small Cell Lung Cancer (NSCLC) with clear histological subtyping and complete postoperative TNM staging.
- Primary tumor SUVmax > 2.5 and maximum diameter > 1.0 cm on CT.
- Complete clinical, pathological, and imaging data available.
Key exclusion criteria (6 listed)
- History of other malignancies.
- Received any anti-tumor treatment (chemotherapy, radiotherapy, targeted therapy, immunotherapy) prior to PET/CT.
- Severe image artifacts or indistinct tumor boundaries affecting ROI delineation.
- Missing key clinical or pathological data.
- Baseline PET/CT evaluated recurrent or metastatic tumors instead of primary NSCLC.
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 Performance for TNM Staging and Histological Subtyping
Time frame: Baseline
Assessed by the Area Under the Receiver Operating Characteristic Curve (AUC), Sensitivity, and Specificity of the radiomics model in predicting T-stage, N-stage, and histological subtypes (ADC vs. SCC).
Predictive Accuracy for EGFR Mutation Status
Time frame: Baseline
Assessed by the AUC, Sensitivity, and Specificity of the radiomics model in discriminating EGFR mutation status (positive vs. negative) compared to genetic testing results.
Prognostic Value
Time frame: From date of surgery up to 5 years
Evaluation of Disease-Free Survival (DFS) and Overall Survival (OS). DFS is defined as time to recurrence or death. OS is defined as time to death from any cause.
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 Mar 2026.
- Individual participant dataSharing planned: Undecided
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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.
Xiaohui Zhang principal investigator
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non Small Cell Lung Cancer, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 4 sites 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 7 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: under way, not looking for participants, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
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?
Diagnostic Performance for TNM Staging and Histological Subtyping (time frame: Baseline). 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 4 Mar 2026.