HealthyNCT01231282
Technique Optimization With Whole-body Diffusion-weighted MRI
A study testing diffusion-weighted MRI in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- diffusion-weighted MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2010to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy volunteers
Who cannot join
- no severe illness in the past
- no current infection/inflammation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers
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.
Read more
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
- Being tested
- diffusion-weighted MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted MRIOther
MRI scan without contrast administration and without radiation exposure
| Study group | Role | What they receive |
|---|---|---|
| diffusion-weighted MRI | Experimental | MRI Receives: Other: diffusion-weighted MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
normal aspect of human anatomy on WB-DWI images/ technique optimization
assessment after all the scans of the healthy volunteers are collected
Measured: up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionOct 2011
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Vandecaveye, Principal investigator, vincent.vandecaveye@uzleuven.be
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231282
- Sponsor's protocol ID
- S52777
- Status last verified
- Oct 2010
- First submitted
- 28 Oct 2010
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 33817648
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technique Optimization and Anatomy of the Human Body With Whole-body Diffusion-weighted MRI: Study With Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01231282
- Acronym / sponsor ID
- S52777
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| diffusion-weighted MRI | Experimental | Other: diffusion-weighted MRIMRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy volunteers
Key exclusion criteria (2 listed)
- no severe illness in the past
- no current infection/inflammation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion-weighted MRIMRI scan without contrast administration and without radiation exposure | Other | diffusion-weighted MRI |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 33817648De 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vincent Vandecaveye principal investigator
vincent.vandecaveye@uzleuven.be
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted MRI in people with Healthy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
normal aspect of human anatomy on WB-DWI images/ technique optimization (time frame: up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231282, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.