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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01482182

Enrollment

Registered

2011-11-30

Start date

2011-11-30

Completion date

2014-01-31

Last updated

2015-11-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small cell lung cancer, Diffusion-weighted MRI, 18F-FDG PET, Treatment response, Prognosis

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

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis	one year	Correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria

Countries

South Korea

Outcome results