Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors (s51240)
Primary Purpose
Gastro-intestinal Tumor, Accurate Staging, Whole-body Diffusion Weighted MRI
Status
Unknown status
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Whole body diffusion MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastro-intestinal Tumor focused on measuring gastro-intestinal tumor, accurate staging, whole-body diffusion weighted MRI, non-invasive
Eligibility Criteria
Inclusion Criteria:
- In principle, all patients treated for gastrointestinal tumors will be included (only with the permission (informed consent) of the patient)
Exclusion Criteria:
- In case of a known contraindication for MRI (eg pacemaker), the patient will not be admitted to the study.
Sites / Locations
- University Hospital Gasthuisberg
Outcomes
Primary Outcome Measures
The aim of the study is to asses whole body diffusion weighted imaging (WB-DWI) in patients with proven gastro-intestinal tumors and to evaluate this non-invasive method for staging and therapy monitoring.
The aim of the study is to asses whole body diffusion weighted imaging (WB-DWI) in patients with proven gastro-intestinal tumors and to evaluate this non-invasive method for staging and therapy monitoring.
Secondary Outcome Measures
Full Information
NCT ID
NCT01224990
First Posted
October 19, 2010
Last Updated
April 9, 2015
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT01224990
Brief Title
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors
Acronym
s51240
Official Title
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Unknown status
Study Start Date
November 2010 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
December 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the study is to assess the value of whole body diffusion weighted MR imaging (WB-DWI) as a non-invasive method. On one hand for pretreatment lesion detection and post-therapeutic tumor recurrence but also for early therapy monitoring with the intention to early identify patients with a poor tumor response. Our research group demonstrated that this technique is accurate in patients with head and neck cancer it could differentiate between viable tumor tissue and inflammatory or necrotic tissue at variable time points after completion of radiotherapy. In the literature it is stated that DWI can also predict the response to chemotherapeutic therapy. This is only true for focal MRI images (eg only in liver). This study aims to determine whether the whole body technique can efficiently be used because the distribution of metastases is systemic. The study includes two phases: In a first phase, a baseline study will be conducted; all possible injury types will be gathered to determine the variability in signal characteristics to finally determine appropriate thresholds to differentiate between benign and malignant lesions. This should allow us later on to perform prospective studies. In a second phase, different applications such as:
pretherapeutic staging
Detection of post-therapy recurrence
Early evaluation of systemic cytotoxic therapy.
The results of the DW-MRI will be compared with those of PET, CT and conventional MRI which are now routinely performed for the diagnosis of colorectal tumors. The scans will be performed in a group of patients on a 3 Tesla MR system. This system is fully approved by the European and American standards and the patients will not be exposed to radiation or contrast agents. In principle, all patients treated for gastrointestinal cancer were included after informed consent from the patient. This study is important to investigate whether DWI is accurate in the pre-therapeutic injury detection and staging of gastrointestinal tumors compared with PET / CT and DWI. In addition it is important to predict the outcome after therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastro-intestinal Tumor, Accurate Staging, Whole-body Diffusion Weighted MRI, Non-invasive
Keywords
gastro-intestinal tumor, accurate staging, whole-body diffusion weighted MRI, non-invasive
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Whole body diffusion MRI
Intervention Description
These studies will be performed on a 3Tesla (T) MR system (Achieva, Philips Medical Systems). A major advantage of 3T compared to 1.5 T 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.
Primary Outcome Measure Information:
Title
The aim of the study is to asses whole body diffusion weighted imaging (WB-DWI) in patients with proven gastro-intestinal tumors and to evaluate this non-invasive method for staging and therapy monitoring.
Description
The aim of the study is to asses whole body diffusion weighted imaging (WB-DWI) in patients with proven gastro-intestinal tumors and to evaluate this non-invasive method for staging and therapy monitoring.
Time Frame
The outcome measure will be assessed during the whole study period (2010-2014)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In principle, all patients treated for gastrointestinal tumors will be included (only with the permission (informed consent) of the patient)
Exclusion Criteria:
In case of a known contraindication for MRI (eg pacemaker), the patient will not be admitted to the study.
Facility Information:
Facility Name
University Hospital Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors
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