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Technique Optimization With Whole-body Diffusion-weighted MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01231282
Recruitment Status : Completed
First Posted : November 1, 2010
Last Update Posted : January 4, 2017
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven

Brief Summary:

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 or disease Intervention/treatment Phase
Healthy Other: diffusion-weighted MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers
Study Start Date : November 2010
Actual Primary Completion Date : October 2011
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anatomy Body Weight

Arm Intervention/treatment
Experimental: diffusion-weighted MRI
Other: diffusion-weighted MRI
MRI scan without contrast administration and without radiation exposure

Primary Outcome Measures :
  1. normal aspect of human anatomy on WB-DWI images/ technique optimization [ Time Frame: up to 12 months ]
    assessment after all the scans of the healthy volunteers are collected

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • no severe illness in the past
  • no current infection/inflammation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01231282

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University Hospitals Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Vincent Vandecaveye
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Responsible Party: Universitaire Ziekenhuizen Leuven Identifier: NCT01231282    
Other Study ID Numbers: S52777
First Posted: November 1, 2010    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: October 2010
Additional relevant MeSH terms:
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Body Weight
Signs and Symptoms