Visualization Study on Tumor Progression Mechanisms and Key Molecular Functions in Neoadjuvant Immunotherapy for Lung Cancer: Preoperative Efficacy Prediction and Intraoperative Fluorescence Navigation
New imaging techniques to predict lung cancer treatment response
Plain English Summary
FAP-targeted PET/NIR in Lung Malignant Tumors is a Not Applicable clinical trial sponsored by Peking University People's Hospital studying Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy. This study tests new imaging methods (FAPI-PET/CT and fluorescence imaging) to see if they can accurately predict how well lung cancer will respond to treatment before surgery. It is for patients with a specific type of lung cancer (stage II-IIIB non-small cell lung cancer) who are about to receive standard pre-surgery treatment. Participation involves undergoing these specialized imaging scans before surgery and having the tumor located during surgery using a special light system. Currently, predicting treatment response relies on standard imaging and pathology after treatment; this study aims to improve early prediction. The trial aims to enroll 200 participants.
Official 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. 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. Patients aged 18-70 with newly diagnosed lung cancer confirmed by biopsy. Patients must be able to undergo standard pre-surgery treatment (chemotherapy, immunotherapy, or a combination). Patients cannot have other types of cancer or have received other cancer treatments before this study. Patients must provide enough tumor tissue for research and have good quality imaging scans. This trial is studying Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcomes measure how accurately the new imaging techniques can identify the extent of the tumor after treatment and before surgery, helping doctors understand if the treatment is working. The specific primary outcome measures are: Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy (From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)); Diagnostic performance of preoperative FAPI PET for treatment response assessment (From preoperative imaging to postoperative pathological assessment (within 4 weeks)). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial matters because it aims to improve the prediction of treatment effectiveness for lung cancer patients, potentially leading to more personalized and successful treatment strategies. This research targets Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy, where improved treatment options are needed.
Investor Insight
This study explores advanced diagnostic tools in a growing area of oncology, potentially improving patient outcomes and offering a competitive edge in precision medicine for lung cancer.
Is This Trial Right for Me?
Ask your doctor if these new imaging techniques are suitable for your specific type and stage of lung cancer. Be prepared for multiple imaging appointments before your surgery. You will have a specialized imaging scan one week before surgery and a fluorescence-guided procedure during surgery. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 200 participants
Interventions
- DIAGNOSTIC_TEST: PET/CT scans — 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 acquisi
Primary Outcomes
- Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy (From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery))
- Diagnostic performance of preoperative FAPI PET for treatment response assessment (From preoperative imaging to postoperative pathological assessment (within 4 weeks))
Secondary Outcomes
- Correlation between fluorescence signal intensity and pathological features (Postoperative specimen analysis (within 2-3 weeks after surgery))
- Tumor-to-background ratio (TBR) of fluorescence imaging in surgical specimens (Postoperative specimen analysis (within 2-3 weeks after surgery))
Full Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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
- Peking University People's Hospital, Beijing, Beijing Municipality, China
Frequently Asked Questions
What is clinical trial NCT07498933?
NCT07498933 is a Not Applicable OBSERVATIONAL study titled "FAP-targeted PET/NIR in Lung Malignant Tumors." It is currently recruiting and is sponsored by Peking University People's Hospital. The trial targets enrollment of 200 participants.
What conditions does NCT07498933 study?
This trial investigates treatments for Non-Small Cell Lung Cancer, PET/CT, Neoadjuvant Therapy. The primary condition under study is Non-Small Cell Lung Cancer.
What treatments are being tested in NCT07498933?
The interventions being studied include: PET/CT scans (DIAGNOSTIC_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 acquisi
What does Not Applicable mean for NCT07498933?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT07498933?
This trial is currently "Recruiting." It started on 2025-06-03. The estimated completion date is 2027-12-31.
Who is sponsoring NCT07498933?
NCT07498933 is sponsored by Peking University People's Hospital. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07498933?
The trial aims to enroll 200 participants. The trial is currently recruiting and accepting new participants.
How is NCT07498933 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07498933?
The primary outcome measures are: Accuracy of EB-FAPI fluorescence imaging for tumor bed delineation after neoadjuvant therapy (From surgery to completion of postoperative pathological evaluation (within 2 weeks after surgery)); Diagnostic performance of preoperative FAPI PET for treatment response assessment (From preoperative imaging to postoperative pathological assessment (within 4 weeks)). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07498933 being conducted?
This trial is being conducted at 1 site, including Beijing, Beijing Municipality (China).
Where can I find official information about NCT07498933?
The official record for NCT07498933 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07498933. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07498933 testing in simple terms?
This study tests new imaging methods (FAPI-PET/CT and fluorescence imaging) to see if they can accurately predict how well lung cancer will respond to treatment before surgery. It is for patients with a specific type of lung cancer (stage II-IIIB non-small cell lung cancer) who are about to receive standard pre-surgery treatment.
Why is this trial significant?
This trial matters because it aims to improve the prediction of treatment effectiveness for lung cancer patients, potentially leading to more personalized and successful treatment strategies.
What are the potential risks of participating in NCT07498933?
The main risks are related to the imaging procedures themselves, such as radiation exposure from PET/CT scans, though these are generally within standard limits. Potential side effects from the tracer used in FAPI-PET/CT are not fully detailed but are expected to be minimal. The accuracy of the new imaging methods may not be perfect, and there's a possibility of misinterpreting treatment response. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07498933?
Ask your doctor if these new imaging techniques are suitable for your specific type and stage of lung cancer. Be prepared for multiple imaging appointments before your surgery. You will have a specialized imaging scan one week before surgery and a fluorescence-guided procedure during surgery. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07498933 signal from an investment perspective?
This study explores advanced diagnostic tools in a growing area of oncology, potentially improving patient outcomes and offering a competitive edge in precision medicine for lung cancer. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing these specialized imaging scans before surgery and having the tumor located during surgery using a special light system. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.