The Use of Molecular Radiogenomics in Non-small Cell Lung Cancer

NCT05541744 | Recruiting DMC

• 1 other identifier: IRB111-168-A
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Lung cancer is currently the leading cause of cancer-related mortality worldwide, and the dominant histopathology is non-small cell lung cancer (NSCLC). Although many new targeted and immunomodulation therapies have emerged, not all patients are responsive to novel therapeutics. A more reliable and accurate risk stratification model to predict the treatment response and survival outcomes are still lacking. The 18F-fluorodeoxyglucose (18F-FDG) positron emission tomography (PET) derived radiomics can be used to interrogate tumor biologies such as glycolytic activity and heterogeneity. It can, therefore, be used to predict treatment response and survival outcomes. Cancer genomics derived from gene sequencing can evaluate cancer's genetic alterations. It can be used to feature the genotype of the tumor. However, both tools have drawbacks; combining these two modalities may enable a more robust predictive model for more precise clinical decisions. During the investigator's former study project, the investigators published four Science Citation Index journal papers using the investigators' research results, which found that 18F-FDG PET radiomics can independently predict regional lymph node metastasis in NSCLC and cancer survival by stage. The preliminary findings of the investigator's former research project also disclosed an association between 18F-FDG PET-derived molecular radiomics with genomic heterogeneity and mutation of specific glucose metabolic genes. This time, the investigators plan to include deep radiomics in addition to traditional handcrafted radiomics. The investigators aim to investigate the radiogenomic patterns in different driver gene mutation statuses and clinical scenarios. Finally, the investigators seek to use radiogenomics as a prognostic stratification tool in patients with NSCLC.

Conditions

Lung Cancer

Keywords

non-small cell lung cancer; Radiogenomics; 18F-FDG PET; whole exome sequencing; molecular imaging

Outcome Measures

Primary Outcomes (1)

• Prognosis

  Study the association of radiogenomics with the treatment response and survival

  three years

Secondary Outcomes (1)

• Correlation of radiogenomics

  one year

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with non-small cell lung cancer, and able to be analyzed with radiomics of FDG PET and primary tumor whole exome sequencing.

You may qualify if:

• Age at least 20-years
• Pathological proven non-small cell lung cancer and received complete staging work-up
• Pre-treatment pathological specimen of the primary tumor

You may not qualify if:

• Coexistence of non-aerodigestive tract cancer.
• Unable to comply to FDG PET/CT exam or poor image quality
• Unable to determine the primary tumor

Sponsors & Collaborators

• Buddhist Tzu Chi General Hospital: lead

Study Sites (1)

Hualien Tzu Chi Hospital

Hualien City, Taiwan

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Yu-Hung Chen, M.D.

CONTACT

886-3-8561825; jedimasterchen@hotmail.com

Study Design

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

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 15, 2022
• Study Start: August 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2028
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)