HealthyNCT02666638
Technical Development of up to 7T Magnetic Field Strength
A study testing Clinical Volunteers in people with Healthy, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this study is to determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 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?
- Clinical Volunteers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2015to 24 Mar 2022
- 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 control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)
Who cannot join
- Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
The objective of this study is to determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 200 Control volunteers will be scanned for approximately one hour, without contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly developed imaging software or hardware that conforms to applicable FDA standards and recommendations. The data (images) for the Control and Experimental Group will be de-identified by the scan technologist and downloaded to a workstation within the Radiology Department for offline processing. These images will be reviewed by a trained Radiologist after the subject has departed.
- Conditions
- Healthy
- Being tested
- Control Volunteers, Clinical Volunteers
- Keywords
- Magnetic Resonance Imaging (MRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Control VolunteersOther
MRI on up to a 7T scanner without contrast.
Clinical VolunteersOther
One-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils
| Study group | Role | What they receive |
|---|---|---|
| Control Volunteers | Active comparator | MRI on up to a 7T scanner without contrast. Receives: Other: Control Volunteers |
| Clinical Patients | Experimental | MRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans. Receives: Other: Clinical Volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in signal to noise ratio using statistical analysis
Measured: 25 minutes
Change in spatial resolution using statistical analysis
Measured: 25 minutes
Change in Temporal Resolution using statistical analysis
Measured: 25 minutes
Change in Image Contrast using statistical analysis
Measured: 25 Minutes
Change in image homogeneity using statistical analysis
Measured: 25 minutes
Change in artifact reduction using statistical analysis
Measured: 25 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study start18 Sep 2015
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongxian Qian, MD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02666638
- Sponsor's protocol ID
- 14-01932
- Status last verified
- Mar 2022
- First submitted
- 21 Jan 2016
- Last updated
- 1 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technical Development of up to 7T Magnetic Field Strength
- ClinicalTrials.gov ID
- NCT02666638
- Acronym / sponsor ID
- 14-01932
- Conditions
- Healthy
- Keywords
- Magnetic Resonance Imaging (MRI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 18 Sep 2015 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 28 Jan 2016 (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.
The objective of this study is to determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 200 Control volunteers will be scanned for approximately one hour, without contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly developed imaging software or hardware that conforms to applicable FDA standards and recommendations. The data (images) for the Control and Experimental Group will be de-identified by the scan technologist and downloaded to a workstation within the Radiology Department for offline processing. These images will be reviewed by a trained Radiologist after the subject has departed.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Volunteers | Active comparator | Other: Control VolunteersMRI on up to a 7T scanner without contrast. |
| Clinical Patients | Experimental | Other: Clinical VolunteersMRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)
Key exclusion criteria (1 listed)
- Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)
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 |
|---|---|---|
| Control VolunteersMRI on up to a 7T scanner without contrast. | Other | Control Volunteers |
| Clinical VolunteersOne-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils | Other | Clinical Patients |
Primary outcome
Change in signal to noise ratio using statistical analysis
Time frame: 25 minutes
Change in spatial resolution using statistical analysis
Time frame: 25 minutes
Change in Temporal Resolution using statistical analysis
Time frame: 25 minutes
Change in Image Contrast using statistical analysis
Time frame: 25 Minutes
Change in image homogeneity using statistical analysis
Time frame: 25 minutes
Change in artifact reduction using statistical analysis
Time frame: 25 minutes
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 1 Apr 2022.
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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.
Yongxian Qian, MD principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Volunteers in people with Healthy, run by NYU Langone Health at 1 site in United States.
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 1 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 1 Apr 2022. 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 United States. 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?
Change in signal to noise ratio using statistical analysis (time frame: 25 minutes). The study lists 6 primary outcomes in all. 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 1 Apr 2022.