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Completed

NCT Number: NCT01482182

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

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).

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

  1. 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

  2. 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.

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Collaborators

  • Guerbet

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Nov 30, 2011
Registry last updated
Nov 20, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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