Healthy VolunteersNCT02411864
Optimal Low B-value in Intravoxel Incoherent Motion Diffusion-weighted MR Imaging of the Brain
An observational study of Healthy Volunteers, run by Tang-Du Hospital.
Trial summary
Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain. Read more about this study
- Who is it for?
- Ages 25 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- different low b-values distribution
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2014to Dec 2014
- Phase
- Observational
- 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 25 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: healthy volunteers
Who may be able to join
- no hypertension or cerebral vascular diseases,
- no systemic metabolic disease;
- no infection or fever;
- no use of corticosteroid drugs;
- no MRI contraindication.
Who cannot join
None listed.
About this study
Official title: Can the Distribution of Low B-value and the NEX Influence the Pseudodiffusion Parameter Derived From IVIM in Brain?
Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.
Read the detailed description
As an improved MRI technique, diffusion-weighted imaging (DWI) is considered the most sensitive for early pathological changes. Perfusion measurement has been shown to improve sensitivity and predictive value for tumor grading and prognosis, also as a predicator of recovery with reperfusion in patients of acute ischemic stroke.Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.
- Conditions
- Healthy Volunteers
- Being tested
- different low b-values distribution
- Keywords
- IVIM, brain, diffusion-weighted imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
different low b-values distributionOther
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Low b=(0,50,150,200)，NEX=(1,3,2,2) Receives: Other: different low b-values distribution | |
| Group 2 | Low b=(0,30,50,100,200)，NEX=(1,3,3,2,2) Receives: Other: different low b-values distribution | |
| Group 3 | Low b=(0,30,60,90,120,150,180,200)，NEX=(1,3,3,3,2,2,2,2) Receives: Other: different low b-values distribution | |
| Group 4 | Low b=(0,30,60,90,120,150,180,200)，NEX=(1,1,1,1,1,1,1,1) | |
| Group 5 | Low b=(0,20,40,60,80,100,120,140,160,180,200)NEX=(1,3,3,3,3,2,2 Receives: Other: different low b-values distribution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parameters D* and f in healthy white matter or gray mater
Measured: 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startNov 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tang-Du Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411864
- Sponsor's protocol ID
- TDLL-20140570
- Status last verified
- Jul 2017
- First submitted
- 10 Dec 2014
- Last updated
- 5 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can the Distribution of Low B-value and the NEX Influence the Pseudodiffusion Parameter Derived From IVIM in Brain?
- ClinicalTrials.gov ID
- NCT02411864
- Acronym / sponsor ID
- TDLL-20140570
- Conditions
- Healthy Volunteers
- Keywords
- IVIM, brain, diffusion-weighted imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tang-Du HospitalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 8 Apr 2015 (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.
Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.
Detailed description
As an improved MRI technique, diffusion-weighted imaging (DWI) is considered the most sensitive for early pathological changes. Perfusion measurement has been shown to improve sensitivity and predictive value for tumor grading and prognosis, also as a predicator of recovery with reperfusion in patients of acute ischemic stroke.Our research aims to reveal whether the low b-values distribution and the number of NEX for each b value will influence the accuracy of pseudodiffusion parameter derived from IVIM in brain.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: different low b-values distributionLow b=(0,50,150,200)，NEX=(1,3,2,2) |
| Group 2 | – | Other: different low b-values distributionLow b=(0,30,50,100,200)，NEX=(1,3,3,2,2) |
| Group 3 | – | Other: different low b-values distributionLow b=(0,30,60,90,120,150,180,200)，NEX=(1,3,3,3,2,2,2,2) |
| Group 4 | – | –Low b=(0,30,60,90,120,150,180,200)，NEX=(1,1,1,1,1,1,1,1) |
| Group 5 | – | Other: different low b-values distributionLow b=(0,20,40,60,80,100,120,140,160,180,200)NEX=(1,3,3,3,3,2,2 |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- healthy volunteers
Key inclusion criteria (5 listed)
- no hypertension or cerebral vascular diseases,
- no systemic metabolic disease;
- no infection or fever;
- no use of corticosteroid drugs;
- no MRI contraindication.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| different low b-values distribution | Other | Group 1, Group 2, Group 3, Group 5 |
Primary outcome
Parameters D* and f in healthy white matter or gray mater
Time frame: 2-3 days
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 5 Jul 2017.
Related trials for Healthy Volunteers
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
RecruitingPhase 1
First-in-Human Evaluation of [11C]JMJ-129-d2 for PDE4D Imaging in Healthy Volunteers
Healthy
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Tang-Du Hospital.
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 5 inclusion and 0 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 5 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Parameters D* and f in healthy white matter or gray mater (time frame: 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jul 2017.