Non-invasive Clinical Trial
Official title:
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.
n/a
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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