Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been completed.
Information provided by (Responsible Party):
Samsung Medical Center Identifier:
First received: November 17, 2011
Last updated: November 17, 2015
Last verified: October 2015
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).

Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis [ Time Frame: one year ]
    Correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria

  • Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis [ Time Frame: 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.

Enrollment: 35
Study Start Date: November 2011
Study Completion Date: January 2014
Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients with advanced NSCLC

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01482182

Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Ho Yun Lee, Dr. Samsung Medical Center
  More Information

Responsible Party: Samsung Medical Center Identifier: NCT01482182     History of Changes
Other Study ID Numbers: 2011-05-087
Study First Received: November 17, 2011
Last Updated: November 17, 2015

Keywords provided by Samsung Medical Center:
Non-small cell lung cancer
Diffusion-weighted MRI
Treatment response

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms processed this record on April 28, 2017