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

This study has been completed.
Sponsor:
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
  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)

  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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on October 19, 2014