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

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2016 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Ho Yun Lee, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01585545
First received: April 21, 2012
Last updated: October 12, 2016
Last verified: October 2016

April 21, 2012
October 12, 2016
October 2013
December 2018   (final data collection date for primary outcome measure)
Functional and genomic profiling of lung cancer [ Time Frame: five years ] [ Designated as safety issue: No ]

Prognostic stratification will be evaluated using following parameters:

  1. Quantitative and qualitative parameters from CT, PET, MRI
  2. Genomic data of lung cancer samples
functional and genetic profile of lung cancer [ Time Frame: two years ] [ Designated as safety issue: No ]

following parameters will be calculated using these values:

  1. Metabolic parameters on FDG-PET
  2. Perfusion parameters on DCE-MRI
  3. Diffusion parameters on DWI
  4. Mutation analysis of lung cancer tissue
Complete list of historical versions of study NCT01585545 on ClinicalTrials.gov Archive Site
  • Relationship between genomic and multiparametric imaging profiling [ Time Frame: five years ] [ Designated as safety issue: No ]
    We will evaluate if certain relationship exists between changes in multiparametric imaging markers from CT, PET, MRI and genomic informations of NSCLC.
  • Precise prediction of pulmonary function such as ventilation and perfusion after the lung resection. [ Time Frame: five years ] [ Designated as safety issue: No ]
    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 genetic and multiparametric imaging profiling [ Time Frame: two years ] [ Designated as safety issue: No ]
We will evaluate if certain relationship exists between changes in multiparametric imaging markers(metabolic parameters on FDG-PET, perfusion parameters on DCE-MRI, diffusion parameters on DWI) and genetic mutation pattern of NSCLC.
Not Provided
Not Provided
 
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
Radiomic Assessment in NSCLC: Correlation Between Multiparametric Imaging Biomarkers and Genetic Biomarkers
The purpose of this study is to evaluate relationships between multiparametric imaging biomarkers and genetic analysis in NSCLC patients.
To evaluate relationships between multiparametric imaging biomarkers(CT, PET/CT, MRI) and genetic analysis in NSCLC patients
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
lung cance tissue
Non-Probability Sample
The patients with non-small cell lung cancer
Lung Cancer
Not Provided
patients with NSCLC
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
December 2020
December 2018   (final data collection date for primary outcome measure)

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
Both
20 Years and older   (Adult, Senior)
No
Contact: Ho Yun Lee, Dr 82-2-3410-2502 ext 82-2-3410-2502 hoyunlee96@gmail.com
Korea, Republic of
 
NCT01585545
2012-03-068
Yes
Not Provided
Not Provided
Ho Yun Lee, Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Ho Yun Lee, Dr Samsung Medical Center
Samsung Medical Center
October 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP