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

This study is currently recruiting participants.
Verified June 2012 by Samsung Medical Center
Sponsor:
Collaborator:
Guerbet
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01482182
First received: November 17, 2011
Last updated: December 4, 2013
Last verified: June 2012
  Purpose

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).


Condition
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    (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.


Estimated Enrollment: 35
Study Start Date: November 2011
Estimated 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
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients with advanced NSCLC

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01482182

Contacts
Contact: Ho Yun Lee, Dr. 82-2-3410-2502 hoyunlee96@gmail.com
Contact: Doyeon Kim dy1214.kim@samsung.com

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of
Contact: Lee       hj0503.lee@samsung.com   
Principal Investigator: Ho Yun Lee         
Sponsors and Collaborators
Samsung Medical Center
Guerbet
Investigators
Principal Investigator: Ho Yun Lee, Dr. Samsung Medical Center
  More Information

No publications provided

Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01482182     History of Changes
Other Study ID Numbers: 2011-05-087
Study First Received: November 17, 2011
Last Updated: December 4, 2013
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Non-small cell lung cancer
Diffusion-weighted MRI
18F-FDG PET
Treatment response
Prognosis

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 17, 2014