Gastrointestinal Stromal TumorsNCT01265979
WB-DWI for Early Prediction of Therapy Response in Patients With Advanced Metastatic GIST Treated With Regorafenib
An observational study of Gastrointestinal Stromal Tumors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gastrointestinal Stromal Tumors
- What is being tested?
- Whole body diffusion MRI
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2011to Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Who may be able to join
- patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Who cannot join
- in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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
- Conditions
- Gastrointestinal Stromal Tumors
- Being tested
- Whole body diffusion MRI
- Keywords
- advanced, metastatic, gastro-intestinal, stromal, GIST, regorafenib
- Medical subject headings
- Gastrointestinal Stromal Tumors, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole body diffusion MRIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| GIST treated with regorafenib/placebo | patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo Receives: Procedure: Whole body diffusion MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: jan 2011-dec 2011
Secondary outcomes (1)
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)
Measured: jan 2011-dec 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2010 (estimated)
- Study startJan 2011
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal Stromal TumorsStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, katrijn Michielsen, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Vincent Vandecaveye, Prof.Dr., Principal investigator, University Hospital Gasthuisberg, department of Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01265979
- Sponsor's protocol ID
- S52989
- Status last verified
- Apr 2015
- First submitted
- 22 Dec 2010
- Last updated
- 10 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01265979
- Acronym / sponsor ID
- S52989
- Conditions
- Gastrointestinal Stromal Tumors
- Keywords
- advanced, metastatic, gastro-intestinal, stromal, GIST, regorafenib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 23 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GIST treated with regorafenib/placebo | – | Procedure: Whole body diffusion MRIpatients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Key inclusion criteria (1 listed)
- patients with advanced, metastatic gastro-intestinal stromal tumors treated with regorafenib or placebo
Key exclusion criteria (1 listed)
- in case of a known contraindication for MRI (eg. pacemaker), the patient will not be admitted to the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Whole body diffusion MRIThese 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. | Procedure or surgery | GIST treated with regorafenib/placebo |
Primary outcome
WB-DWI as early predictor for regorafenib treatment response
Time frame: jan 2011-dec 2011
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)
1 secondary outcome
Evaluation WB-DWI parameters in correlation with progression free survival (PFS)
Time frame: jan 2011-dec 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Vandecaveye, Prof.Dr. principal investigator
University Hospital Gasthuisberg, department of Radiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Stromal Tumors, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WB-DWI as early predictor for regorafenib treatment response (time frame: jan 2011-dec 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2015.