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

Completed

• Conditions: Non-small Cell Lung Cancer

• Registration Number: NCT01482182
• Lead Sponsor: Samsung Medical Center

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

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2011-11-17
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-30
• Primary Completion: 2013-11
• Study Completion: 2014-01
• Status Verified: 2015-10
• Last Update Submitted: 2015-11-17
• Last Update Posted: 2015-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis	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 Outcome Measures

Name	Time	Method
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis	one year	(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.

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of