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

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.

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Key information

Conditions

Gastrointestinal Stromal Tumors Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

Radiology Department

Leuven, 3000, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Whole body diffusion MRI

Procedure

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.

Primary outcomes

WB-DWI as early predictor for regorafenib treatment response

Time frame: 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 outcomes

Evaluation WB-DWI parameters in correlation with progression free survival (PFS)

Time frame: 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)

Sponsors and collaborators

Lead sponsor

Universitaire Ziekenhuizen KU Leuven

Other

Registry information

Official study title

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.

Important dates

Study start: 2011
Primary completion: 2011
Study completion: 2011
First posted: Dec 23, 2010
Registry last updated: Apr 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed