Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02059889|
Recruitment Status : Withdrawn (slow accrual)
First Posted : February 11, 2014
Last Update Posted : December 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Recurrent Non-small Cell Lung Cancer Stage IIA Non-small Cell Lung Cancer Stage IIB Non-small Cell Lung Cancer Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer||Device: diffusion-weighted magnetic resonance imaging Device: 4-dimensional computed tomography Radiation: fludeoxyglucose F 18 Device: FDG-PET||Not Applicable|
I. Assess diffusion-weighted MRI as an early predictor for tumor response in patients with non-small cell lung cancer (NSCLC).
II. Establish the potential of individualized radiotherapy targeting of radioresistant tumor sub-volumes.
Patients undergo diffusion-weighted MRI within 4 weeks of radiation start (baseline), during the second week of radiation therapy, during the fourth week of radiation therapy, and at 3 months after radiation therapy (post-treatment). Patients also undergo standard of care 4-dimensional (4D) computed tomography (CT) and fludeoxyglucose F 18 (FDG)-positron emission tomography (PET) at the same time points.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diffusion-weighted MRI for Individualized Radiation Therapy Planning of Lung Cancer|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Diagnostic (diffusion-weighted MRI, 4D CT, FDG-PET)
Patients undergo 15 imaging studies: 5 chest CT scans, 5 chest MRI scans, 5 PET scans. Each scan will be obtained before treatment begins, weeks 2 and 4 during radiation therapy, 3 months and 1 year following radiation therapy. THe chest CT obtained pre-treatment, at 3 months post treatment and 1 year post treatment are considered routine and would be obtained regardless of study participation. The pre-treatment PET scan is also considered routine. All other scans are being done for the purposes of this research.
Device: diffusion-weighted magnetic resonance imaging
Undergo diffusion-weighted MRI
Other Name: diffusion-weighted MRI
Device: 4-dimensional computed tomography
Undergo 4D CT
Other Name: 4D-CT
Radiation: fludeoxyglucose F 18
Other Name: 18FDG, 2-F18-fluoro-2-deoxyglucose, 63503-12-8, FDG, Fluorine-18 2-Fluoro-2-deoxy-D-Glucose, fluorodeoxyglucose F 18, Fluorodeoxyglucose F18
Other Name: FDG-PET, PET, PET scan, tomography, emission computed
- Measurement of gross tumor volume and involved lymph nodes [ Time Frame: Up to 3 months ]A paired sample t-test could be applied to test the difference between MRI, CT, and PET-CT contours. Parameters used for comparison will include volume size, volume overlap, such as Dice similarity coefficients and Jaccard index, and surface distance maps including Hausdorff distance.
- Change in functional response [ Time Frame: Baseline to 3 months ]Patients will be classified into responders and non-responders based on their PET signal which will serve as the reference method for response assessment. Although this is a little different from the three group analysis of variance (ANOVA) used in the power calculation, it is expected that there will be similar high power when the partial responders and non-responders are combined. Receiver operating characteristic (ROC) analysis will be used to define a threshold of apparent diffusion coefficient (ADC) change to stratify between metabolic responders vs. non-responders.
- Spatial concordance of multimodality imaging for whole image registration [ Time Frame: Up to 3 months ]A paired sample t-test will be used.
- Temporospatial registrations of radioresistant sub-volumes [ Time Frame: Up to 3 months ]A paired sample t-test will be used. ROC analysis will be performed only for radioresistant sub-volumes to identify which diffusion weighted-MRI functional signal thresholds correlate with levels of tumor activity defined on PET.
- Change in ADC [ Time Frame: Baseline to 4 weeks ]Fourth week ADC change will be compared to metabolic response defined by the fourth week PET using three group ANOVA and ROC analysis.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059889
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Elisabeth Weiss, MD||Massey Cancer Center|