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.

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.

Study Overview

• Status: Completed
• Conditions: Gastrointestinal Stromal Tumors
• Intervention / Treatment: Procedure: Whole body diffusion MRI

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)

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

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Belgium
  • Leuven, Belgium, 3000
    • Radiology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo

Description

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 Plan

How is the study designed?

Design Details

• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Vincent Vandecaveye, Prof.Dr., University Hospital Gasthuisberg, department of Radiology

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): September 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: December 22, 2010
• First Submitted That Met QC Criteria: December 22, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): April 10, 2015
• Last Update Submitted That Met QC Criteria: April 9, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: metastatic; advanced; regorafenib; GIST; gastro-intestinal; stromal
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Neoplasms, Connective Tissue; Gastrointestinal Stromal Tumors
• Other Study ID Numbers: S52989

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No