Non Small Cell Lung CancerNCT05970913
PET-CT Predicting Lymph Nodes Metastasis
An observational study of Non Small Cell Lung Cancer and Lymph Node Metastasis, run by Fudan University at 1 site in China.
Trial summary
This study is a single-center prospective clinical study that aims to evaluate the predictive value of preoperative 18F-FDG-PET-CT and 18F-FAPI-PET/CT for lymph node metastasis in patients with non-small cell lung cancer. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Non Small Cell Lung Cancer, Lymph Node Metastasis, Positron Emission Tomography
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 28 Mar 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients had non small cell lung cancer who received pathological examination of lymph nodes
Who may be able to join
- Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from the primary lesion.
- Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.
- Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
- No prior radiotherapy or chemotherapy for initial treatment.
- No history of malignant tumors.
Who cannot join
- Locally advanced or distant metastasis.
- Pleural dissemination observed during surgery.
- History of malignant tumors.
- Received neoadjuvant therapy.
- Histopathological examination reveals lung malignancies other than non-small cell lung cancer (NSCLC).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Value of PET-CT in Predicting Lymph Nodes Metastasis in Non Small Cell Lung Cancer
This study is a single-center prospective clinical study that aims to evaluate the predictive value of preoperative 18F-FDG-PET-CT and 18F-FAPI-PET/CT for lymph node metastasis in patients with non-small cell lung cancer. The final pathological results were used to assess the predictive value of PET-CT for lymph node metastasis.
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung, Lymphatic Metastasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive value of 18F-FDG-PET/CT and 18F-FAPI-PET/CT for lymph node metastasis
Measured: from enrollment to 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2023
- Study start1 Nov 2023
- Primary completion28 Mar 2026 (estimated)
- Study completion28 Mar 2026 (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 Fudan UniversityThe 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
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haiquan Chen, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05970913
- Sponsor's protocol ID
- ECTOP-1017
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2023
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Value of PET-CT in Predicting Lymph Nodes Metastasis in Non Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT05970913
- Acronym / sponsor ID
- ECTOP-1017
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 28 Mar 2026 (estimated)
- Study completion
- 28 Mar 2026 (estimated)
- First posted
- 1 Aug 2023 (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 is a single-center prospective clinical study that aims to evaluate the predictive value of preoperative 18F-FDG-PET-CT and 18F-FAPI-PET/CT for lymph node metastasis in patients with non-small cell lung cancer. The final pathological results were used to assess the predictive value of PET-CT for lymph node metastasis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients had non small cell lung cancer who received pathological examination of lymph nodes
Key inclusion criteria (5 listed)
- Solitary tumor, or multiple tumors with only ground-glass nodules (GGNs) apart from the primary lesion.
- Diameter of the primary lesion ≤5cm, with a CTR between 0.5 and 1.
- Pathological confirmation of non-small cell lung cancer (NSCLC) either before or during surgery.
- No prior radiotherapy or chemotherapy for initial treatment.
- No history of malignant tumors.
Key exclusion criteria (5 listed)
- Locally advanced or distant metastasis.
- Pleural dissemination observed during surgery.
- History of malignant tumors.
- Received neoadjuvant therapy.
- Histopathological examination reveals lung malignancies other than non-small cell lung cancer (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
Predictive value of 18F-FDG-PET/CT and 18F-FAPI-PET/CT for lymph node metastasis
Time frame: from enrollment to 1 month after surgery
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 23 Mar 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?
An observational study of Non Small Cell Lung Cancer and Lymph Node Metastasis, run by Fudan 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 5 inclusion and 5 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 23 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 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?
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?
Predictive value of 18F-FDG-PET/CT and 18F-FAPI-PET/CT for lymph node metastasis (time frame: from enrollment to 1 month after 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 23 Mar 2026.