Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors (s51240)

This study is currently recruiting participants.
Verified September 2011 by Universitaire Ziekenhuizen Leuven
Sponsor:
Information provided by (Responsible Party):
katrijn Michielsen, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01224990
First received: October 19, 2010
Last updated: September 27, 2011
Last verified: September 2011

October 19, 2010
September 27, 2011
November 2010
November 2014   (final data collection date for primary outcome measure)
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) ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01224990 on ClinicalTrials.gov Archive Site
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Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors
Whole Body Diffusion MRI for Non-invasive Lesion Detection and Therapy Follow-up: Study With Patients With Gastro-intestinal Tumors.

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Gastro-intestinal Tumor
  • Accurate Staging
  • Whole-body Diffusion Weighted MRI
  • Non-invasive
Procedure: Whole body diffusion MRI
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.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
November 2014   (final data collection date for primary outcome measure)

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.
Both
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No
Contact: Ilse Roebben, Master in Biomedical Sciences 016 349074 ilse.roebben@uzleuven.be
Contact: Katrijn Michielsen, Master in Biomedical Sciences 016 349076 katrijn.michielsen@uzleuven.be
Belgium
 
NCT01224990
s51240
No
katrijn Michielsen, Universitaire Ziekenhuizen Leuven
Universitaire Ziekenhuizen Leuven
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Universitaire Ziekenhuizen Leuven
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP