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

Completed

• Conditions: Gastrointestinal Stromal Tumors
• Interventions: Procedure: Whole body diffusion MRI

• Registration Number: NCT01265979
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

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

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)

1. 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)

2. 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)

3. 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)

4. Comparison of WB-DWI with conventional CT imaging for response assessment

Study Timeline

• Study First Submitted: 2010-12-22
• Study First Submitted QC: 2010-12-22
• Study First Posted: 2010-12-23
• Study Start: 2011-01
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-09
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GIST treated with regorafenib/placebo	Whole body diffusion MRI	patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo

Primary Outcome Measures

Name	Time	Method
WB-DWI as early predictor for regorafenib treatment response	jan 2011-dec 2011	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)

Secondary Outcome Measures

Name	Time	Method
Evaluation WB-DWI parameters in correlation with progression free survival (PFS)	jan 2011-dec 2011	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)

Trial Locations

Locations (1)

Radiology Department; 🇧🇪 Leuven, Belgium