Non-Small Cell Lung CancerNCT07498933
FAP-targeted PET/NIR in Lung Malignant Tumors
An observational study of Non-Small Cell Lung Cancer and PET/CT, run by Peking University People's Hospital at 1 site in China.
Trial summary
Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy
- What is being tested?
- PET/CT scans
- Type of treatment
- Injection or infusion
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 3 Jun 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy
Who may be able to join
- Age between 18 and 70 years old;
- Have complete clinical and imaging data;
- Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer;
- Able to retain sufficient tumor tissue for testing and research;
- Sign informed consent.
Who cannot join
- Previously combined with other malignant tumors or received other anti-tumor treatments;
- Failure to collect sufficient tumor tissue for testing and research;
- The duration of neoadjuvant therapy is less than 3 cycles;
- The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing;
- Lack of clinical and imaging data;
- There are situations where other researchers consider it inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Qingyun Liu, MD contact
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality
Kezhong Chen, MD, +86-010-88325983, mdkzchen@163.com
About this study
Official title: Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET/fluorescence were compared and analyzed.
Read the detailed description
This is a prospective, exploratory clinical study designed to evaluate the role of FAP-targeted imaging in efficacy prediction and tumor bed delineation in patients with NSCLC undergoing surgical resection after neoadjuvant therapy. Following neoadjuvant treatment, enrolled patients will undergo preoperative FAP-targeted PET imaging to assess treatment response and identify metabolically active tumor-associated stromal regions. Surgical resection will be performed according to standard clinical practice. Immediately after tumor resection, ex vivo fluorescence imaging of the surgical specimen will be conducted using a EB-FAPI fluorescence probe. Based on fluorescence signal distribution, systematic multipoint sampling will be performed across tumor center, tumor margin, and adjacent normal tissues. Routine pathological sampling will be conducted in parallel according to standard protocols. Additional fluorescence-guided sampling will be performed in regions with persistent fluorescence signals. Histopathological analysis will be used as the reference standard to evaluate tumor bed distribution, residual tumor presence, and pathological response. The concordance between fluorescence imaging, PET imaging, and pathological findings will be analyzed. The study will also evaluate whether fluorescence-guided sampling can improve detection of residual tumor and reduce false-negative pathological assessments. This study aims to establish a multimodal imaging approach integrating preoperative molecular imaging and intraoperative fluorescence guidance to enhance tumor bed visualization and improve the accuracy of pathological response assessment after neoadjuvant therapy in NSCLC.
- Conditions
- Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy
- Being tested
- PET/CT scans
- Keywords
- PET Imaging, NIR Imaging, Neoadjuvant Therapy, Non-Small Cell Lung Cancer
- 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.
PET/CT scansDiagnostic test
PET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases.
| Study group | Role | What they receive |
|---|---|---|
| FAP-targeted PET in lung malignant tumors | Participant who conforms to the inclusion criteria will undergo 68Ga-FAPI/EB-FAPI PET/CT scans within 1 week. Receives: Diagnostic Test: PET/CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy
To evaluate the accuracy of intraoperative FAP-targeted fluorescence imaging in identifying the tumor bed after neoadjuvant therapy in NSCLC patients, using histopathological assessment as the reference standard. Tumor bed regions identified by fluorescence will be compared with pathological mapping of tumor, regression bed, and residual tumor distribution.
Measured: From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)
Diagnostic performance of preoperative FAPI PET for treatment response assessment
To evaluate the ability of preoperative FAPI PET imaging to predict pathological response after neoadjuvant therapy, using pathological response (pCR/MPR/non-MPR) as the reference standard.
Measured: From preoperative imaging to postoperative pathological assessment (within 4 weeks)
Secondary outcomes (2)
Correlation between fluorescence signal intensity and pathological features
To evaluate the correlation between fluorescence signal intensity and pathological parameters, including tumor cell density, regression bed, and FAP expression (e.g., immunohistochemistry), across tumor (T), margin (M), and normal (N) regions.
Measured: Postoperative specimen analysis (within 2-3 weeks after surgery)
Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens
To quantify fluorescence signal contrast between tumor, tumor margin, and normal tissues, and determine optimal thresholds for tumor bed delineation.
Measured: Postoperative specimen analysis (within 2-3 weeks after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start3 Jun 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Non-Small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen KeZhong, Peking University People's Hospital
- Investigators
- Kezhong Chen, MD, Study director, Peking University People's HospitalJun Wang, M.M., Study chair, Peking University People's HospitalHao Li, MD, Principal investigator, Peking University People's HospitalYuan Li, MD, Principal investigator, Peking University People's HospitalZhaohui Zhu, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07498933
- Sponsor's protocol ID
- 2101000672
- Status last verified
- May 2025
- First submitted
- 23 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Chen K, Yang F, Shen H, Wang C, Li X, Chervova O, Wu S, Qiu F, Peng D, Zhu X, Chuai S, Beck S, Kanu N, Carbone D, Zhang Z, Wang J. Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer. Cancer Cell. 2023 Oct 9;41(10):1749-1762.e6. doi: 10.1016/j.ccell.2023.08.010. Epub 2023 Sep 7.
PubMed 37683638Gangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19.
PubMed 33221195Kennedy GT, Azari FS, Bernstein E, Marfatia I, Din A, Kucharczuk JC, Low PS, Singhal S. Targeted Intraoperative Molecular Imaging for Localizing Nonpalpable Tumors and Quantifying Resection Margin Distances. JAMA Surg. 2021 Nov 1;156(11):1043-1050. doi: 10.1001/jamasurg.2021.3757.
PubMed 34431971Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.
PubMed 37019717
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
- ClinicalTrials.gov ID
- NCT07498933
- Acronym / sponsor ID
- 2101000672
- Conditions
- Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy
- Keywords
- PET Imaging, NIR Imaging, Neoadjuvant Therapy, Non-Small Cell Lung Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 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.
Single center, prospective, diagnostic study. Patients with stage II-IIIB resectable NSCLC diagnosed by pathology were included. After receiving standard neoadjuvant therapy (chemotherapy/immunotherapy/combination therapy), FAPI-PET/CT and fluorescence imaging were performed one week before surgery. During the surgery, a near-infrared fluorescence navigation system was used to locate the tumor lesion. After surgery, the tumor bed range was determined by pathological gold standards (HE staining+immunohistochemistry), and the predictive efficacy and localization accuracy of FAPI-PET/fluorescence were compared and analyzed.
Detailed description
This is a prospective, exploratory clinical study designed to evaluate the role of FAP-targeted imaging in efficacy prediction and tumor bed delineation in patients with NSCLC undergoing surgical resection after neoadjuvant therapy. Following neoadjuvant treatment, enrolled patients will undergo preoperative FAP-targeted PET imaging to assess treatment response and identify metabolically active tumor-associated stromal regions. Surgical resection will be performed according to standard clinical practice. Immediately after tumor resection, ex vivo fluorescence imaging of the surgical specimen will be conducted using a EB-FAPI fluorescence probe. Based on fluorescence signal distribution, systematic multipoint sampling will be performed across tumor center, tumor margin, and adjacent normal tissues. Routine pathological sampling will be conducted in parallel according to standard protocols. Additional fluorescence-guided sampling will be performed in regions with persistent fluorescence signals. Histopathological analysis will be used as the reference standard to evaluate tumor bed distribution, residual tumor presence, and pathological response. The concordance between fluorescence imaging, PET imaging, and pathological findings will be analyzed. The study will also evaluate whether fluorescence-guided sampling can improve detection of residual tumor and reduce false-negative pathological assessments. This study aims to establish a multimodal imaging approach integrating preoperative molecular imaging and intraoperative fluorescence guidance to enhance tumor bed visualization and improve the accuracy of pathological response assessment after neoadjuvant therapy in NSCLC.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FAP-targeted PET in lung malignant tumors | – | Diagnostic Test: PET/CT scansParticipant who conforms to the inclusion criteria will undergo 68Ga-FAPI/EB-FAPI PET/CT scans within 1 week. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with lung cancer who plan to receive neoadjuvant immunotherapy combined with chemotherapy
Key inclusion criteria (5 listed)
- Age between 18 and 70 years old;
- Have complete clinical and imaging data;
- Prior to neoadjuvant therapy, the biopsy pathology showed lung cancer;
- Able to retain sufficient tumor tissue for testing and research;
- Sign informed consent.
Key exclusion criteria (6 listed)
- Previously combined with other malignant tumors or received other anti-tumor treatments;
- Failure to collect sufficient tumor tissue for testing and research;
- The duration of neoadjuvant therapy is less than 3 cycles;
- The dynamic scanning image quality of multimodal probe PET cannot meet the analysis standards or is missing;
- Lack of clinical and imaging data;
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 |
|---|---|---|
| PET/CT scansPET Dynamic Data: The tracer is administered based on the patient's body weight at approximately 0.06-0.12 mCi/kg. PET scanning is initiated simultaneously with tracer injection, followed by a flush with 10 ml of normal saline. The image acquisition matrix is 192 × 192. Reconstruction is performed using the OSEM algorithm with 4 iterations and 20 subsets, incorporating time-of-flight attenuation correction, scatter correction, and random correction. The total duration of PET dynamic data acquisition is 60 minutes. Processing of PET dynamic scan data: Dynamic PET images are divided into 2-minute intervals to obtain time-activity curves by extracting the radioactivity within regions of interest at different time points, reflecting tracer uptake and enabling calculation of the time to peak. Multi-modality imaging data are analyzed by radiologists with over 10 years of experience in diagnosing respiratory diseases. | Diagnostic test | FAP-targeted PET in lung malignant tumors |
Primary outcome
Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy
Time frame: From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)
To evaluate the accuracy of intraoperative FAP-targeted fluorescence imaging in identifying the tumor bed after neoadjuvant therapy in NSCLC patients, using histopathological assessment as the reference standard. Tumor bed regions identified by fluorescence will be compared with pathological mapping of tumor, regression bed, and residual tumor distribution.
Diagnostic performance of preoperative FAPI PET for treatment response assessment
Time frame: From preoperative imaging to postoperative pathological assessment (within 4 weeks)
To evaluate the ability of preoperative FAPI PET imaging to predict pathological response after neoadjuvant therapy, using pathological response (pCR/MPR/non-MPR) as the reference standard.
2 secondary outcomes
Correlation between fluorescence signal intensity and pathological features
Time frame: Postoperative specimen analysis (within 2-3 weeks after surgery)
Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens
Time frame: Postoperative specimen analysis (within 2-3 weeks 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 1 Apr 2026.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 37683638Chen K, Yang F, Shen H, Wang C, Li X, Chervova O, Wu S, Qiu F, Peng D, Zhu X, Chuai S, Beck S, Kanu N, Carbone D, Zhang Z, Wang J. Individualized tumor-informed circulating tumor DNA analysis for postoperative monitoring of non-small cell lung cancer. Cancer Cell. 2023 Oct 9;41(10):1749-1762.e6. doi: 10.1016/j.ccell.2023.08.010. Epub 2023 Sep 7.
- Background: PubMed 33221195Gangadharan S, Sarkaria IN, Rice D, Murthy S, Braun J, Kucharczuk J, Predina J, Singhal S. Multiinstitutional Phase 2 Clinical Trial of Intraoperative Molecular Imaging of Lung Cancer. Ann Thorac Surg. 2021 Oct;112(4):1150-1159. doi: 10.1016/j.athoracsur.2020.09.037. Epub 2020 Nov 19.
- Background: PubMed 34431971Kennedy GT, Azari FS, Bernstein E, Marfatia I, Din A, Kucharczuk JC, Low PS, Singhal S. Targeted Intraoperative Molecular Imaging for Localizing Nonpalpable Tumors and Quantifying Resection Margin Distances. JAMA Surg. 2021 Nov 1;156(11):1043-1050. doi: 10.1001/jamasurg.2021.3757.
- Background: PubMed 37019717Sarkaria IS, Martin LW, Rice DC, Blackmon SH, Slade HB, Singhal S; ELUCIDATE Study Group. Pafolacianine for intraoperative molecular imaging of cancer in the lung: The ELUCIDATE trial. J Thorac Cardiovasc Surg. 2023 Dec;166(6):e468-e478. doi: 10.1016/j.jtcvs.2023.02.025. Epub 2023 Mar 3.
- Individual participant dataSharing planned: No
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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.
Qingyun Liu, MD contact
Kezhong Chen, MD study director
Peking University People's Hospital
Jun Wang, M.M. study chair
Peking University People's Hospital
Hao Li, MD principal investigator
Peking University People's Hospital
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 PET/CT, run by Peking University People's 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 5 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: looking for participants now, as of the sponsor's last update on 1 Apr 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?
Contact Kezhong Chen, MD (+86-010-88325983, mdkzchen@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy (time frame: From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)). The study lists 2 primary outcomes in all. 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 NCT07498933, which also lists 5 linked publications.
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 1 Apr 2026.