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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Samsung Medical Center
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis
Study 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:
- 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
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 20 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)