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

NCT03679936 | Unknown

• 1 other identifier: ZDWY.FZYX.002
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in metastasis of non-small cell lung cancer (NSCLC). The investigators will collect dynamic 18F-FDG PET/CT scan and correlate the imaging findings with genomics and histopathological features of biopsy of primary or / and metastatic lesions in patients with newly diagnosed non-small cell lung cancer (NSCLC). At the same time, the investigators will evaluate the diagnostic value of 18F-FDG PET/CT dynamic imaging in differentiating multiple primary lung cancer from intrapulmonary metastases.

Conditions

Positron-Emission Tomography; Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Calculating the overall diagnostic sensitivity and specificity and ROC

  For each patient enrolled in the study, a two-chamber four-parameter model (2TCM) and a Patlak two-parameter model are established using 18F-FDG PET/CT dynamic scans. Summarizing these dynamic model parameters for all enrolled patients separately calculates the overall diagnostic sensitivity and specificity. Calculate ROC based on sensitivity and specificity.

  60 minutes

Secondary Outcomes (1)

• Calculating the overall diagnostic sensitivity and specificity and summarizing the intrinsic correlation

  60 minutes

Study Arms (4)

Non-metastatic group

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Metastatic group

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Multiple primary lung cancer group

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Intrapulmonary metastases group

PET/CT dynamic scan,needle biopsy and gene detection

Diagnostic Test: PET/CT dynamic scan

Interventions

PET/CT dynamic scan DIAGNOSTIC_TEST

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.

Also known as: Needle biopsy, Gene detection

Intrapulmonary metastases group; Metastatic group; Multiple primary lung cancer group; Non-metastatic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

More than 18 years old and less than 65 years old, no gender limitation, first diagnosis of non-small cell lung cancer patients, patients who must comply with all the inclusion criteria are eligible to participate in this study.However,patients who meet any of the exclusion criteria will not be eligible to participate in this study.

You may qualify if:

• Accurately diagnosing primary liver cancer according to pathological diagnostic criteria or clinical diagnostic 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.

You may not qualify if:

• Poorly controlled diabetics (fasting blood glucose levels \> 200 mg/dL).
• 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).

Sponsors & Collaborators

• Fifth Affiliated Hospital, Sun Yat-Sen University: lead

Study Sites (1)

Hongjun Jin

Zhuhai, Guangzhou, 519000, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 31974680 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

needle biopsy of tumor tissue

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Biopsy, Needle

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Punctures; Investigative Techniques

Central Study Contacts

Jin

CONTACT

0756-2526136; jinhj3@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 21, 2018
• Study Start: January 3, 2018
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

CN (1)