Diagnostic Significance of Single Center, Open and Prospective Evaluation of <Sup>18<Sup>F-FDG PET/CT Dynamic Imaging and Genomic Sequencing in Detecting Metastatic Lesions and Differentiating Multiple Primary Lung Cancer From Intrapulmonary Metastases of Non-small Cell Lung Cancer
NCT ID: NCT03679936
Last Updated: 2022-04-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
120 participants
OBSERVATIONAL
2018-01-03
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of the Gene Mutation Status in Cerebrospinal Fluid, Blood and Tumor Tissue of Non-small Cell Lung Cancer Patients With Brain Metastases
NCT03257735
Decoding the Association of Imaging and Tumor Microenvironment in Lung Cancer Using Radiogenomic Approach(Radiogenomics-Lung)
NCT06500312
Comparison of 68Ga-FAPI-46 PET and 18F-FDG PET in Lung Cancer
NCT05617742
AIMN Multicenter Study: 18 F-FDG PET-CT With or Without Contrast Medium in the Staging and Radiation of Lung Cancer?
NCT06168916
Dynamic PET/CT Evaluated the Response of Neoadjuvant Anti-PD1 Combination With Chemotherapy for Ⅱa-Ⅲb NSCLC
NCT04586465
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
As a new imaging technique, 18F-FDG PET/CT plays a more and more important role in the diagnosis of tumor. 18F-FDG PET/CT reflects the process of glucose metabolism in tumor tissue. The diagnosis of benign and malignant tumors is based on the difference of glucose metabolism activity between tumor cells and normal tissue cells. 18F-FDG is the isomer of glucose, which participates in the process of glucose metabolism. Because it cannot produce hexose diphosphate because of its deoxidation, it cannot participate in the next metabolism, and it is retained in cells. Due to the high expression of glucose transport mRNA,the level of Glut-1 and Glut-3 increased, the expression of hexokinase increased, and the level of glucose-6-phosphatase decreased, which resulted in an increase of 18F-FDG uptake in tumor cells \[5\]. Molecular imaging using 18F-FDG PET / CT can provide metabolic information, which can make benign and malignant tissues differentiate better, and reveal the functional abnormalities before structural damage \[6\]. However, the current PET/CT scans reported in the relevant literature are based on conventional static scans, i.e. the image data is based on a static take-up image of the tracer in tissue obtained at a fixed time point after the injection of 18F-FDG. To improve, the investigators propose to use dynamic data scanning, which captures the dynamic data of whole body tissues collected from the moment of injecting 18F-FDG to an hour. Dynamic scans can provide information on the dynamic changes in tracer metabolism and distribution in tissues over time, so they provide a richer metabolic and distributional pattern of tumor foci and metastases than static scans. Therefore, the aim of this study is to make up for this gap by performing a dynamic scan of 18F-FDG PET/CT on newly diagnosed patients with non-small cell lung cancer. The lesions and/or metastases are performed for biopsy. Pathological and genomic studies are performed. The differences between tumor images and tissues are compared at the same time. 18F-FDG PET/CT dynamic imaging is explored in non-small cell lung cancer metastases for the diagnostic value.At the same time, the ability to differentiate multiple primary lung cancer from intrapulmonary metastases of 18F-FDG PET/CT dynamic imaging will be dissussed .
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Non-metastatic group
PET/CT dynamic scan,needle biopsy and gene detection
PET/CT dynamic scan
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
Metastatic group
PET/CT dynamic scan,needle biopsy and gene detection
PET/CT dynamic scan
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
Multiple primary lung cancer group
PET/CT dynamic scan,needle biopsy and gene detection
PET/CT dynamic scan
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
Intrapulmonary metastases group
PET/CT dynamic scan,needle biopsy and gene detection
PET/CT dynamic scan
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PET/CT dynamic scan
This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC),for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Tumor volume (\> 1 cm) displayed by enhanced CT or MRI or liver mass confirmed by arteriography .
* For patients considering distant metastases, trunk metastases need to be confirmed by CT examination. Bone metastases need to be confirmed by whole-body bone scan. Brain metastases need to be confirmed with characteristic metastatic tumors by MRI.
* The age is more than 18 years old and less than 65 years old. There is no gender restriction.
* Untreated patients who have not received surgery, interventional therapy, chemotherapy, biotherapy, and radiation therapy.
* Physical condition score ECOG: 0-2; no major organ dysfunction; oxygen partial pressure ≥ 10.64kPa; white blood cell count≥ 4 × 109/L; hemoglobin ≥ 9.5g/dL; neutrophil absolute count ≥ 1.5 × 109 / L; platelet count ≥ 100 × 109 / L; total bilirubin ≤ 1.5 times of the upper limit of normal value; creatinine ≤ 1.25 times of the upper limit of normal value; and creatinine clearance ≥ 60ml / min.
* Be able to obtain complete follow-up information, understand the situation of this study and sign informed consent.
Exclusion Criteria
* In addition to four types of malignant tumors that can be treated with radical resection, such as cervical cancer in situ, basal or squamous cell skin cancer, (breast) ductal carcinoma in situ, and organ localized prostate cancer, suffering from any other malignant tumors within 5 years.
* Breastfeeding and/or pregnant women.
* Patients with severe bleeding tendencies (prothrombin time less than 50%, cannot be corrected by treatment with vitamin K, etc.).
* Recent severe hemoptysis, severe cough, dyspnea or patients are not able to cooperate.
* People with severe emphysema, pulmonary congestion, and pulmonary heart disease.
* Researchers believe that the subject may not be able to complete this study or may not be able to comply with the requirements of this study (for management reasons or other reasons).
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hongjun Jin
Zhuhai, Guangzhou, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Yang M, Lin Z, Xu Z, Li D, Lv W, Yang S, Liu Y, Cao Y, Cao Q, Jin H. Influx rate constant of 18F-FDG increases in metastatic lymph nodes of non-small cell lung cancer patients. Eur J Nucl Med Mol Imaging. 2020 May;47(5):1198-1208. doi: 10.1007/s00259-020-04682-5. Epub 2020 Jan 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ZDWY.FZYX.002
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.