Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers

• Conditions: Lung Cancer

• Registration Number: NCT01585545
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.

Detailed Description

To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients

Study Timeline

• Study First Submitted: 2012-04-21
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Study Start: 2013-10
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-03
• Last Update Posted: 2022-05-05
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Suspected lung cancer on chest CT or histologically proven NSCLC
• Participant is being considered for the conventional/neoadjuvant/targeted chemotherapy or surgery
• At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST
• Performance status of 0 to 2 on the ECOG scale
• Age 20 years or older
• Able to tolerable PET/CT and CT imaging required by protocol
• Able to undergo percutaneous needle biopsy before and after chemotherapy
• Able to give study-specific informed consent

Exclusion Criteria

• Poorly controlled diabetes
• Contraindication for CT contrast agent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Functional and genomic profiling of lung cancer	five years	Prognostic stratification will be evaluated using following parameters: 1. Quantitative and qualitative parameters from CT, PET, MRI; 2. Genomic data of lung cancer samples

Secondary Outcome Measures

Name	Time	Method
Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.	five years	following parameters exracted from whole lung will be evaluated: Quantitative parameters related to pulmonary function from CT, PET, MRI 2. Prediction of longitudinal changes of pulmonary function after the lung resection
Relationship between genomic and multiparametric imaging profiling	five years	We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of