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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01265979

Enrollment

Registered

2010-12-23

Start date

2011-01-31

Completion date

2011-09-30

Last updated

2015-04-10

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

Conditions

Gastrointestinal Stromal Tumors

Keywords

advanced, metastatic, gastro-intestinal, stromal, GIST, regorafenib

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

Interventions

PROCEDUREWhole body diffusion MRI

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.

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026