Image, BodyPhase 4Avery HSNCT05215132
Investigational MRI Clinical Software and Hardware
A Phase 4 study testing MRI and Gadavist 2Ml Solution for Injection in people with Image, Body, run by Northwestern University at 1 site in United States.
Trial summary
Patients and healthy volunteers will be scanned in order to test new sequences. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Image, Body
- What is being tested?
- MRI and Gadavist 2Ml Solution for Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2019to 31 Jan 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • At least 18 years of age
- Able to complete the MR safety questionnaire.
- Able to comprehend and provide informed consent in English.
- When contrast is being administered: healthy volunteers with a GFR≥60 ml/min
- When contrast is being administered: patients with a GFR ≥30 ml/min
Who cannot join
- • When contrast is being administered: subjects with a GFR < 30 ml/min
- When contrast is being administered: subjects with acute kidney injury
- When contrast is administered, allergy to gadolinium-containing contrast media
- Contraindication to MRI (implanted device, claustrophobia, dyspnea precluding the ability to follow breath-hold instructions)
- Adults unable to consent
- Individuals who are not yet adults
- Pregnant or breastfeeding women
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University- Feinberg School of Medicine
Chicago, Illinois, 60611
About this study
Official title: Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
Patients and healthy volunteers will be scanned in order to test new sequences.
Read the detailed description
The aims of this study are to:
- Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
- Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.
- Conditions
- Image, Body
- Being tested
- MRI, Gadavist 2Ml Solution for Injection
- Keywords
- MRI hardware testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIRadiation
1.5T or 3T MRI scanner (Siemens Medical Systems)
Gadavist 2Ml Solution for InjectionDrug
Arm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution)
| Study group | Role | What they receive |
|---|---|---|
| Patient w/ Contrast | Other | Patients will add 15 minutes to their SOC MRI for research purposes Receives: Radiation: MRI; Drug: Gadavist 2Ml Solution for Injection |
| Patient no contrast | Other | Patients will add 15 minutes to their SOC MRI for research purposes Receives: Radiation: MRI |
| Volunteer w/ contrast | Other | Volunteers undergo 1 research MRI for research purposes Receives: Radiation: MRI; Drug: Gadavist 2Ml Solution for Injection |
| Volunteer no contrast | Other | Volunteers undergo 1 research MRI for research purposes Receives: Radiation: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conduct clinical protocol development and validation
Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.
Measured: 5 years
Secondary outcomes (1)
Demonstrate and train
Human subjects may be scanned utilizing MRI pulse sequences in the context of a clinical assessment for demonstrating of equipment or sequence function for training of MRI technologist. The sequence will be performed by a skilled technologist with the primary goal of providing information on proper utilizing of MRI hardware and software for technologist who are training and will be possibly utilizing these technique to provided safe and effective use of MRI systems and their software.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start19 Dec 2019
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Image, BodyStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- If a research MRI is combined with a clinically ordered MRI, the research scan will add about 15 minutes to the clinical MRI procedure. If a research MRI is conducted during a separate visit, it is expected that the research-only MRI visit will last about 1-2 hours. An individual may voluntarily participate in the study on multiple occasions.
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ryan Avery, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05215132
- Sponsor's protocol ID
- STU#00211312
- Acronym
- Avery HS
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2021
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The research team may use the data obtained from this study for future institutionally approved studies not yet identified but conducted by Feinberg School of Medicine investigators. This means that information about you, including your name, date of birth, study data, etc. may be given to investigators not currently working on this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Evaluation of Feasibility and Reproducibility of Investigational MRI Clinical Software
- ClinicalTrials.gov ID
- NCT05215132
- Acronym / sponsor ID
- Avery HS / STU#00211312
- Conditions
- Image, Body
- Keywords
- MRI hardware testing
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 19 Dec 2019 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jan 2028 (estimated)
- First posted
- 31 Jan 2022 (actual)
- 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.
Patients and healthy volunteers will be scanned in order to test new sequences.
Detailed description
The aims of this study are to:
- Conduct clinical protocol development and validation: The settings of an MRI machine are commonly adjusted according to the body part being scanned and the reason for the exam. When testing out new sequences and settings or adjusting existing settings, human subjects (patients and healthy volunteers) may be scanned in order to make sure that the quality of the images produced by the MRI machine is adequate for diagnostic purposes and to obtain normative values.
- Demonstrate and train: In some cases, human subjects may be scanned for the purposes of demonstrating equipment or for training operators on the safe and effective use of MRI systems.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- If a research MRI is combined with a clinically ordered MRI, the research scan will add about 15 minutes to the clinical MRI procedure. If a research MRI is conducted during a separate visit, it is expected that the research-only MRI visit will last about 1-2 hours. An individual may voluntarily participate in the study on multiple occasions.
| Arm | Type | Receives |
|---|---|---|
| Patient w/ Contrast | Other | Radiation: MRI, Drug: Gadavist 2Ml Solution for InjectionPatients will add 15 minutes to their SOC MRI for research purposes |
| Patient no contrast | Other | Radiation: MRIPatients will add 15 minutes to their SOC MRI for research purposes |
| Volunteer w/ contrast | Other | Radiation: MRI, Drug: Gadavist 2Ml Solution for InjectionVolunteers undergo 1 research MRI for research purposes |
| Volunteer no contrast | Other | Radiation: MRIVolunteers undergo 1 research MRI for research purposes |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- • At least 18 years of age
Key exclusion criteria (8 listed)
- • When contrast is being administered: subjects with a GFR < 30 ml/min
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 |
|---|---|---|
| MRI1.5T or 3T MRI scanner (Siemens Medical Systems) | Radiation | Patient no contrast, Patient w/ Contrast, Volunteer no contrast, Volunteer w/ contrast |
| Gadavist 2Ml Solution for InjectionArm 1 and Arm 3 subjects will undergo this intervention (Gadavist 2Ml solution) | Drug | Patient w/ Contrast, Volunteer w/ contrast |
Primary outcome
Conduct clinical protocol development and validation
Time frame: 5 years
Testing of new MRI pulse sequences will be performed for validation of potential new diagnostic capabilities. The MRI pulse sequences will be routinely performed along with clinically-validated and accepted pulse sequences for comparison of the novel sequences in human subjects (patients and healthy volunteers). Novel sequences will be performed in the accepted method with adjustment of settings to evaluate image qualities and normative values produced by the MRI machine. The resulting images provided by the novel sequences will be able to evaluated for diagnostic quality and to obtain comparison of possible improvements alongside clinically-validated MRI pulse sequences.
1 secondary outcome
Demonstrate and train
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Yes. The research team may use the data obtained from this study for future institutionally approved studies not yet identified but conducted by Feinberg School of Medicine investigators. This means that information about you, including your name, date of birth, study data, etc. may be given to investigators not currently working on this study.
Related trials for Image, Body
RecruitingObservational study
Glucose Levels and Outcomes in Women - Mid Pregnancy
Pregnancy
Enrolling by invitation
Basic Body Awareness Therapy (BBAT) and Corrective Exercise for Adolescent Hyperkyphosis
Hyperkyphosis, Adolescent
Not yet recruiting
Development, Implementation, and Evaluation of the HADAS Program for the Prevention of Eating Disorders in Adolescent Female Athletes, Coaches, and Families.
Eating Disorders, Body Image Dissatisfaction
Recruiting
Prenatal Yoga Intervention in Pregnant Women
Pregnant Women, Prenatal Yoga
Not yet recruiting
Brief Single-Session Body Neutrality Program for LGBTQ+ Adults in Central Alabama
Body Image
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MRI and Gadavist 2Ml Solution for Injection in people with Image, Body, run by Northwestern University 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 5 inclusion and 8 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: under way, not looking for participants, as of the sponsor's last update on 15 Sep 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Conduct clinical protocol development and validation (time frame: 5 years). 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 15 Sep 2026.