Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers
Recruitment status was Recruiting
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Purpose
Whole body diffusion-weighted imaging is a functional magnetic resonance imaging technique that characterizes tissue by probing changes in water diffusion secondary to differences in the tissue microstructure. These changes in water diffusion result in differences in signal intensity on diffusion-weighted images that are quantified with the apparent diffusion coefficient (ADC). In malignant lesions, the extravascular extracellular space (EES) will be diminished, due to the increased number of cells. This will restrict water diffusion, identified by increased signal intensity (SI) on native diffusion-weighted images and low ADC. Contrary, in tissue with low cellularity, like benign lesions and treatment induced necrosis, the EES will be enlarged due to the lower density of cells, or in case of necrosis, the complete absence of cellular organization. This will facilitate water diffusion, leading to absent SI on native diffusion-weighted images and high ADC.
The purpose of this study is to image anatomy and lymph nodes in healthy volunteers with whole body diffusion-weighted imaging. This way maps of normal anatomy can be created on the whole body diffusion-weighted images which can be used as a reference in further studies with patients scanned with the same whole body diffusion-weighted imaging scan protocol.
A group of 30 healthy volunteers will receive a whole body diffusion-weighted imaging scan on a 3 Tesla T-MRI system.
A total scan session will take about 30 minutes. Contrast administration is not required and patients will not be exposed to radiation.
| Condition | Intervention |
|---|---|
|
Healthy |
Procedure: Whole-body diffusion-weighted MRI |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label |
| Official Title: | Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers |
- normal aspect of human anatomy on WB-DWI images/ technique optimization [ Time Frame: up to 12 months ] [ Designated as safety issue: No ]assessment after all the scans of the healthy volunteers are collected
| Estimated Enrollment: | 30 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | April 2013 |
| Primary Completion Date: | October 2011 (Final data collection date for primary outcome measure) |
-
Procedure: Whole-body diffusion-weighted MRI
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- healthy volunteers
Exclusion Criteria:
- no severe illness in the past
- no current infection/inflammation
Contacts and Locations| Contact: Vincent Vandecaveye, MD PhD | 3216340518 | vincent.vandecaveye@uzleuven.be |
| Contact: Katja De Paepe, MD | katja.depaepe@uzleuven.be |
| Belgium | |
| University Hospitals Leuven | Recruiting |
| Leuven, Vlaams-Brabant, Belgium, 3000 | |
| Contact: Vincent Vandecaveye, MD PhD 3216340518 vincent.vandecaveye@uzleuven.be | |
| Contact: Katja De Paepe, MD katja.depaepe@uzleuven.be | |
More Information
No publications provided
| Responsible Party: | Universitaire Ziekenhuizen Leuven |
| ClinicalTrials.gov Identifier: | NCT01231282 History of Changes |
| Other Study ID Numbers: | S52777 |
| Study First Received: | October 28, 2010 |
| Last Updated: | January 15, 2013 |
| Health Authority: | Belgium: Institutional Review Board |
ClinicalTrials.gov processed this record on May 22, 2013