Technique Optimization With Whole-body Diffusion-weighted MRI

Healthy Clinical Trial

Official title:

Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231282
• Other study ID #: S52777
• Status: Completed
• Phase: N/A
• First received: October 28, 2010
• Last updated: January 2, 2017
• Start date: November 2010
• Est. completion date: April 2013

Study information

• Verified date: October 2010
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2013
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• healthy volunteers

Exclusion Criteria:

• no severe illness in the past

• no current infection/inflammation

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• diffusion-weighted MRI
MRI scan without contrast administration and without radiation exposure

Locations

Country	Name	City	State
Belgium	University Hospitals Leuven	Leuven	Vlaams-Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	normal aspect of human anatomy on WB-DWI images/ technique optimization	assessment after all the scans of the healthy volunteers are collected	up to 12 months	No