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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Universitaire Ziekenhuizen Leuven.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01231282
First received: October 28, 2010
Last updated: January 15, 2013
Last verified: October 2010
  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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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)
Intervention Details:
    Procedure: Whole-body diffusion-weighted MRI
    MRI scan without contrast administration and without radiation exposure
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • no severe illness in the past
  • no current infection/inflammation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01231282

Contacts
Contact: Vincent Vandecaveye, MD PhD 3216340518 vincent.vandecaveye@uzleuven.be
Contact: Katja De Paepe, MD katja.depaepe@uzleuven.be

Locations
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   
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
  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 November 20, 2014