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

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Xiamen University

Status

Unknown

Conditions

Genomics
Radiomics
Biopsy
PET/CT
Whole-exome Sequencing
NSCLC

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT04553601
KYH2019-039

Details and patient eligibility

About

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

Full 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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

150 participants in 1 patient group

8F-FDG PET/CT and PET/CT-guide targeted biopsy
Experimental group
Description:
Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time.
Treatment:
Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants

Trial contacts and locations

1

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Central trial contact

Haojun Chen, PhD; Long Sun, PhD

Data sourced from clinicaltrials.gov

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