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

May 3, 2022 updated by: Ho Yun Lee, Samsung Medical Center
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The patients with non-small cell lung cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
patients with NSCLC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional and genomic profiling of lung cancer
Time Frame: 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
five years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relationship between genomic and multiparametric imaging profiling
Time Frame: five years
We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC.
five years
Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection.
Time Frame: 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
five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Investigators

  • Principal Investigator: Ho Yun Lee, Dr, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (Anticipated)

December 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 21, 2012

First Submitted That Met QC Criteria

April 23, 2012

First Posted (Estimate)

April 26, 2012

Study Record Updates

Last Update Posted (Actual)

May 5, 2022

Last Update Submitted That Met QC Criteria

May 3, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2012-03-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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