Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy
Conditions
Non-small Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung - Lung Neoplasms
Conditions: Keywords
Non-small cell lung cancer, Diffusion-weighted MRI, 18F-FDG PET, Treatment response, Prognosis
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Case-Only, Time Perspective: Prospective
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 20 Years
Gender: Both
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
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Lee - hj0503.lee@samsung.com
Start Date
November 2011
Completion Date
January 2014
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page