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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04553601
Recruitment Status : Recruiting
First Posted : September 17, 2020
Last Update Posted : September 17, 2020
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital of Xiamen University

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

Condition or disease Intervention/treatment Phase
NSCLC PET/CT Biopsy Radiomics Genomics Whole-exome Sequencing Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants Not Applicable

Detailed Description:
Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors. The LIFEx package was used to extract PET and CT radiomic features from primary and metastatic lesions. The radiomic ROI sites of primary and distant metastatic tumors were point-to-point corresponding to the PET/ CT-guided targeted biopsy sites. Whole exon sequencing of primary and distant metastatic tumor samples obtained by PET/CT-guided targeted biopsy was used to get genomic data of primary and distant metastatic tumor. Predictive radiogenomics models were established and validation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Patients with advanced NSCLC underwent 18F-FDG PET/CT and PET/CT-guided synchronous targeted biopsy of primary and distant metastatic tumors.
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Biopsy

Arm Intervention/treatment
Experimental: 8F-FDG PET/CT and PET/CT-guide targeted biopsy
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
Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time




Primary Outcome Measures :
  1. Radiomic feature selection and model establishment [ Time Frame: 3 years ]
    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.


Secondary Outcome Measures :
  1. Genes mutation detection [ Time Frame: 30 days ]
    Genes mutation detection was performed on histological specimens obtained by surgical resection or puncture. Genes mutation detection was conducted by the examination of the whole-exome sequencing. The whole-exome sequencing is performed by the Novogene company (www.novogene.com). If any genes mutation in the whole-exome sequencing was detected, the tumor was considered genes mutant. Otherwise, the tumor was classified as no mutant of genes type.

  2. Image acquisition [ Time Frame: 30 days ]
    The imaging acquisition protocol was established following the Image Biomarker Standardisation Initiative (IBSI) reporting guidelines. All the details of the procedures are provided in the electronic supplementary material. 18F-FDG PET/CT (Discovery MI, GE Healthcare, Milwaukee, WI, USA) examination was performed within 1 month before treatment. Briefly, 18F-FDG PET/CT images were acquired 60 ± 5 min after 18F-FDG injection in accordance with the European Association of Nuclear Medicine (EANM) guidelines, version 1.0 (version 2.0 from February 2015). A 3D LOR reconstruction algorithm was used to reconstruct the PET images. The attenuation correction of PET images was carried out with CT data, and the corrected PET images were fused with CT images.

  3. Radiomic feature extraction [ Time Frame: 30 days ]
    The LIFEx package (version 4.00, http://www.lifexsoft.org) was used to extract the texture features of PET/CT images of lesions in the same VOI. The PET/CT image of the patient in the DICOM format was imported into the software. Two experienced PET/CT diagnostic physicians semi-automatically delineated the region of interest of the target lesion using a threshold of 40% of the maximum standardized uptake value (SUVmax). Then, the software program automatically calculates and extracts 47 PET radiomic features and 45 CT radiomic features.



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Criteria: Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04553601


Contacts
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Contact: Long Sun, PhD 86 0592-2137077 13178352662@163.com
Contact: Haojun Chen, PhD 86 0592-2137166 leochen0821@foxmail.com

Locations
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China, Fujian
First affiliated hospital of xiamen university Recruiting
XiaMen, Fujian, China, 0086-361000
Contact: Long Sun, doctor    86 0592-2137077    13178352662@163.com   
Sponsors and Collaborators
The First Affiliated Hospital of Xiamen University
Investigators
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Principal Investigator: Long Sun, PhD The First Affiliated Hospital of Xiamen University
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Responsible Party: The First Affiliated Hospital of Xiamen University
ClinicalTrials.gov Identifier: NCT04553601    
Other Study ID Numbers: KYH2019-039
First Posted: September 17, 2020    Key Record Dates
Last Update Posted: September 17, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital of Xiamen University:
NSCLC, PET/CT, radiogenomics
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action