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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


N/A
20 Years
N/A
Open (Enrolling)
Both
Non-small Cell Lung Cancer

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Trial Information

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


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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis

Outcome Description:

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.

Outcome Time Frame:

one year

Safety Issue:

No

Principal Investigator

Ho Yun Lee, Dr.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Samsung Medical Center

Authority:

South Korea: Institutional Review Board

Study ID:

2011-05-087

NCT ID:

NCT01482182

Start Date:

November 2011

Completion Date:

December 2013

Related Keywords:

  • Non-Small Cell Lung Cancer
  • Non-small cell lung cancer
  • Diffusion-weighted MRI
  • 18F-FDG PET
  • Treatment response
  • Prognosis
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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