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Clinical Trials/NCT01482182
NCT01482182
Completed
Not Applicable

Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET

Samsung Medical Center1 site in 1 country35 target enrollmentNovember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Non-small Cell Lung Cancer
Sponsor
Samsung Medical Center
Enrollment
35
Locations
1
Primary Endpoint
DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).

Detailed Description

Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values: 1. Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR 2. Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve 3. Diffusion parameters on DWI A. Mean ADC B. fDM

Registry
clinicaltrials.gov
Start Date
November 2011
End Date
January 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Histologically proven NSCLC
  • Newly diagnosed Stage stage IV
  • Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
  • At least one measurable primary or other intrathoracic lesion \>= 2cm, according to RECIST
  • Performance status of 0 to 2 on the ECOG scale
  • Age 18 years or older
  • Able to tolerable PET/CT and MRI imaging required by protocol
  • Able to give study-specific informed consent

Exclusion Criteria

  • Pure bronchioloalveolar cell carcinoma histology
  • Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
  • Poorly controlled diabetes
  • Prior malignancy

Outcomes

Primary Outcomes

DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis

Time Frame: one year

The primary endpoint of this study is the prediction of one-year overall survival by monitoring the metabolic and functional responses of the tumor following one cycle of chemotherapy.

Secondary Outcomes

  • Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis(one year)

Study Sites (1)

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