WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib
This study has been completed.
Sponsor:
Universitaire Ziekenhuizen Leuven
Information provided by (Responsible Party):
katrijn Michielsen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01265979
First received: December 22, 2010
Last updated: September 27, 2011
Last verified: September 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Gastrointestinal Stromal Tumors |
Procedure: Whole body diffusion MRI |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official 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. |
Resource links provided by NLM:
Further study details as provided by Universitaire Ziekenhuizen Leuven:
Primary Outcome Measures:
- WB-DWI as early predictor for regorafenib treatment response [ Time Frame: jan 2011-dec 2011 ] [ Designated as safety issue: No ]
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:
- Evaluation WB-DWI parameters in correlation with progression free survival (PFS) [ Time Frame: jan 2011-dec 2011 ] [ Designated as safety issue: No ]
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)
| Estimated Enrollment: | 30 |
| Study Start Date: | January 2011 |
| Study Completion Date: | September 2011 |
| Primary Completion Date: | September 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
GIST treated with regorafenib/placebo
patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
|
Procedure: 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.
|
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)
- 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
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01265979
Locations
| Belgium | |
| Radiology Department | |
| Leuven, Belgium, 3000 | |
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
| Principal Investigator: | Vincent Vandecaveye, Prof.Dr. | University Hospital Gasthuisberg, department of Radiology |
More Information
No publications provided
| Responsible Party: | katrijn Michielsen, PhD, Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01265979 History of Changes |
| Other Study ID Numbers: | S52989 |
| Study First Received: | December 22, 2010 |
| Last Updated: | September 27, 2011 |
| Health Authority: | Belgium: Ethics Committee |
Keywords provided by Universitaire Ziekenhuizen Leuven:
|
advanced metastatic gastro-intestinal |
stromal GIST regorafenib |
Additional relevant MeSH terms:
|
Gastrointestinal Stromal Tumors Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases |
ClinicalTrials.gov processed this record on October 18, 2012
