Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy

Study Overview
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Brief Summary
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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
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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: 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 Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve Diffusion parameters on DWI A. Mean ADC B. fDM

Official Title
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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

Conditions
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Non-small Cell Lung Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis | 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. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis | Correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria | one year | 
| Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis | (i) the correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria (ii) the correlation between functional response (metabolic and MR parameters) and progression-free survival (iii) comparison between the predictive values of FDG-PET and MRI for one-year overall survival. | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small cell lung cancer, Diffusion-weighted MRI, 18F-FDG PET, Treatment response, Prognosis