WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib

Study Overview
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Brief Summary
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The purpose of this study is to evaluate WB DWI as early predictor of response to treatment with regorafenib or placebo in patients with advanced metastatic GIST.

Detailed Description
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Aim of the study - To assess whole body diffusion-weighted magnetic resonance imaging (WB-DWI) for the assessment and early prediction of response of treatment with regorafenib or placebo in patients with advanced, metastatic gastro-intestinal stromal tumors (GIST) Evaluation of pretreatment apparent diffusion coefficient (ADC) and b1000 signal intensity (SI) of GIST visualized on the WB-DWI as predictor of time to progression, determined by progression-free survival (PFS) Evaluation of WB-DWI using changes of high b-value SI and ADC early during treatment (2weeks after start of therapy; allowed optimal window 10-14 days) as early predictor of time to progression or patient benefit according to RECIST (stable disease + partial response + complete response) Evaluation of WB-DWI for treatment follow-up 3 months after initiation of treatment. Confirmation of prior published pilot study (Dunet V et al, J Nucl Med 2010) Comparison of WB-DWI with conventional CT imaging for response assessment

Official Title
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Whole Body Diffusion-weighted MRI (WB-DWI) for Early Prediction and Evaluation of Therapy Response in Patients With Advanced Metastatic Gastrointestinal Stromal Tumors (GIST) Treated With Regorafenib.

Conditions
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Gastrointestinal Stromal Tumors

Intervention / Treatment
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* Procedure: Whole body diffusion MRI


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo Exclusion Criteria: in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GIST treated with regorafenib/placebo<br>patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo | Procedure: Whole body diffusion MRI<br>* These studies will be performed on a 3 Tesla (T) MR system. A major advantage of 3T compared to 1.5T is the improved signal to noise ratio that allows whole-body studies to be faster and without application of external antennas, which greatly improves patient comfort.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WB-DWI as early predictor for regorafenib treatment response | Primary aim of the study: To assess whole body diffusion-weighted magnetic resonance imaging (WB-DWI) for the assessment and early prediction of response of treatment with regorafenib or placebo in patients with advanced, metastatic gastro-intestinal stromal tumors (GIST) | jan 2011-dec 2011 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation WB-DWI parameters in correlation with progression free survival (PFS) | Evaluation of pretreatment apparent diffusion coefficient (ADC) and b1000 signal intensity (SI) changes of high b-value SI and ADC early during treatment (2weeks after start of therapy; allowed optimal window 10-14 days) treatment follow-up 3 months after initiation of treatment of GIST visualized on the WB-DWI as predictor of progression free survival (PFS) | jan 2011-dec 2011 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced, metastatic, gastro-intestinal, stromal, GIST, regorafenib