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.
1 other identifier
observational
5
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2011
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 22, 2010
CompletedFirst Posted
Study publicly available on registry
December 23, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2011
CompletedApril 10, 2015
April 1, 2015
8 months
December 22, 2010
April 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Evaluation WB-DWI parameters in correlation with progression free survival (PFS)
jan 2011-dec 2011
Study Arms (1)
GIST treated with regorafenib/placebo
patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Interventions
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.
Eligibility Criteria
patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
You may qualify if:
- patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
You may not qualify if:
- in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Radiology Department
Leuven, Leuven, 3000, Belgium
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vincent Vandecaveye, Prof.Dr.
University Hospital Gasthuisberg, department of Radiology
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
December 22, 2010
First Posted
December 23, 2010
Study Start
January 1, 2011
Primary Completion
September 1, 2011
Study Completion
September 1, 2011
Last Updated
April 10, 2015
Record last verified: 2015-04