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

Gastrointestinal Stromal Tumors Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01265979
• Other study ID #: S52989
• Status: Completed
• Phase: N/A
• First received: December 22, 2010
• Last updated: April 9, 2015
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: April 2015
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Gastrointestinal Stromal Tumors

Intervention

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.

Locations

Country	Name	City	State
Belgium	Radiology Department	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluation WB-DWI parameters in correlation with progression free survival (PFS)	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)	jan 2011-dec 2011	No