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NCT01585545 Clinical Trial

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

Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT01585545
Other study ID # 2012-03-068
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date October 2013
Est. completion date December 2025

Study information
Verified date May 2022
Source Samsung Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 500
Est. completion date December 2025
Est. primary completion date December 2025
Accepts healthy volunteers No
Gender All
Age group 20 Years and older
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Functional and genomic profiling of lung cancer Prognostic stratification will be evaluated using following parameters:
Quantitative and qualitative parameters from CT, PET, MRI
Genomic data of lung cancer samples		 five years
Secondary Relationship between genomic and multiparametric imaging profiling We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC. five years
Secondary Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection. 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 five years
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