WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib
NCT ID: NCT01265979
Last Updated: 2015-04-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
5 participants
OBSERVATIONAL
2011-01-31
2011-09-30
Brief Summary
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Detailed Description
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\- 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
Conditions
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Study Design
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PROSPECTIVE
Study Groups
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GIST treated with regorafenib/placebo
patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Whole 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.
Interventions
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Whole 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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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katrijn Michielsen
PhD
Principal Investigators
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Vincent Vandecaveye, Prof.Dr.
Role: PRINCIPAL_INVESTIGATOR
University Hospital Gasthuisberg, department of Radiology
Locations
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Radiology Department
Leuven, Leuven, Belgium
Countries
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Other Identifiers
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S52989
Identifier Type: -
Identifier Source: org_study_id
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