Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer

NCT04553601 | Unknown DMC

• 1 other identifier: KYH2019-039
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.

Conditions

NSCLC; PET/CT; Biopsy; Radiomics; Genomics; Whole-exome Sequencing

Keywords

NSCLC, PET/CT, radiogenomics

Outcome Measures

Primary Outcomes (1)

• Radiomic feature selection and model establishment

  In this study, the investigators first selected the features with significant differences between genes mutant and wild type in the training set using the Mann-Whitney U test, obtaining a total of 53 features with p value \< 0.05. Then, the least absolute shrinkage and selection operator (LASSO) algorithm was used to select the optimal predictive features among the 53 selected in the training set. The LASSO algorithm adds a L1 regularization term to a least square algorithm to avoid overfitting. A prediction model was established by logistic regression, and the radiomics signature score (rad-score) for each participant was calculated based on the selected discriminating radiomic features. The model performance was tested in the validation set. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the model performance in the training and validation sets.

  3 years

Secondary Outcomes (3)

• Genes mutation detection

  30 days

• Image acquisition

  30 days

• Radiomic feature extraction

  30 days

Study Arms (1)

8F-FDG PET/CT and PET/CT-guide targeted biopsy

EXPERIMENTAL

Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time.

Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants

Interventions

18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants DIAGNOSTIC_TEST

Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time

8F-FDG PET/CT and PET/CT-guide targeted biopsy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (i) adult patients (aged 18 years or order);
• (ii) patients with suspected or newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
• (iii) patients who had scheduled both 18F-FDG PET/CT scans and PET/CT guided biopsy;
• (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.

You may not qualify if:

• (i) patients with non-malignant lesions;
• (ii) patients with pregnancy;
• (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

First affiliated hospital of xiamen university

Xiamen, Fujian, 0086-361000, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Study Officials

• Long Sun, PhD

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Long Sun, PhD

CONTACT

86 0592-2137077; 13178352662@163.com

Haojun Chen, PhD

CONTACT

86 0592-2137166; leochen0821@foxmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: September 17, 2020
• Study Start: October 1, 2019
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: September 17, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)