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

Non-small Cell Lung Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01482182
• Other study ID #: 2011-05-087
• Status: Completed
• Phase: N/A
• First received: November 17, 2011
• Last updated: November 17, 2015
• Start date: November 2011
• Est. completion date: January 2014

Study information

• Verified date: October 2015
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 2014
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-small Cell Lung Cancer

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Samsung Medical Center	Guerbet

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis	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.	one year	No
Secondary	Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis	Correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria	one year	No
Secondary	Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis	(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.	one year	No