Technique Optimization With Whole-body Diffusion-weighted MRI

NCT01231282 | Completed

• 1 other identifier: S52777
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

diffusion-weighted MRI

EXPERIMENTAL

MRI

Other: diffusion-weighted MRI

Interventions

diffusion-weighted MRI OTHER

MRI scan without contrast administration and without radiation exposure

diffusion-weighted MRI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteers

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Vlaams-Brabant, 3000, Belgium

Location

Related Publications (1)

• De Paepe KN, Van Keerberghen CA, Agazzi GM, De Keyzer F, Gheysens O, Bechter O, Wolter P, Dierickx D, Janssens A, Verhoef G, Oyen R, Koole M, Vandecaveye V. Quantitative Whole-Body Diffusion-weighted MRI after One Treatment Cycle for Aggressive Non-Hodgkin Lymphoma Is an Independent Prognostic Factor of Outcome. Radiol Imaging Cancer. 2021 Mar 26;3(2):e200061. doi: 10.1148/rycan.2021200061. eCollection 2021 Mar.

  PMID: 33817648 DERIVED

Study Officials

• Vincent Vandecaveye

  vincent.vandecaveye@uzleuven.be

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2010
• First Posted: November 1, 2010
• Study Start: November 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: April 1, 2013
• Last Updated: January 4, 2017

Record last verified: 2010-10

Locations

BE (1)