Medical OncologyFasterScanNCT05385718
Ezra Faster Scan Study
An observational study of Medical Oncology and Cancer, run by Ezra AI, Inc. at 5 sites in United States.
Trial summary
The Ezra Faster Scan study uses non-invasive magnetic resonance imaging (MRI) technology that can "visually" detect early and late-stage cancer, and other pathologies. MRIs use a magnetic field and radio waves to create a 3-dimensional (3D) image of an individual's body without using ionizing radiation. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Medical Oncology, Cancer, Healthy
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 694 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Jun 2022to 24 Feb 2025
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants may be from the general public and located or able to travel to MRI facilities located in New York, New York; Queens, New York; Brooklyn, New York; Great Neck, New York; Irvine, California; Sunnyvale, California; Walnut Creek, California; San Francisco, California; Miami, Florida; Aventura, Florida. Participants may also be those who have accessed Ezra commercial MRI services in the past, or have scheduled commercial MRI services pending.
Who may be able to join
- Ability to provide legal informed consent and 18 years of age or older
- Resident of the contiguous United States and located within proximity of a designated research MRI facility
- Ability to travel to designated research MRI facilities
Who cannot join
- Unable to receive an MRI due to existing implanted medical devices that may be disrupted by magnetic field or metal components/fragments that may migrate due to magnetic fields (pacemaker or defibrillator, stimulators, or stimulator wires (pacing leads), non-removeable metal dentures/braces/wires, surgical clips, (drug) pumps. Note metallic dental crowns or fillings are permitted.
- Those with orbital (eye socket) trauma caused by a metallic object
- Those with metallic fragments within the eye (foundry workers)
- Those with implanted cardiac pacemakers, implantable cardioverter defibrillators (ICDs), or diaphragmatic pacemakers, cardiac resynchronization therapy devices, implantable cardiovascular monitors, implantable loop recorders, neurostimulators
- Those with intra-cranial vascular clips (aneurysm), or prosthetic heart valve
- Those with shrapnel form a prior accident
Show all 24Show fewer
- Those with a LINX Reflux Management System to control gastro esophageal reflux disease (GERD)
- Those with non-removable insulin pumps or other drug pumps
- Those with cochlear implants
- Those with breast (inflatable breast tissue implants) or other tissue expanders (cosmetic or other implant)
- Those with tubal ligation clips or non-removable intrauterine device (IUD)
- Those with Sensimed Triggerfish ocular monitoring systems (glaucoma)
- Those receiving ambulatory care
- Employee of Ezra Health of California, P.C., Ezra AI Incorporated or Ezra AI Canada Incorporated
- Mental health disability, cognitive disability, neurological or other existing condition that may impact ability to provide informed consent
- Those that recently experienced a stroke that may impair judgement
- Those that have some difficulty or higher, remembering, concentrating, communicating, or being understood (sponsor reviewed)
- Individuals who otherwise may require a legally authorized individual (LAR) to provide consent on their behalf
- Those who do not have access to the internet through a mobile device or computer
- Those who are pregnant at the time of informed consent or prior to a scheduled MRI appointment
- Those who are incarcerated or on probation
- Those who may not have reading proficiency of study supported document languages (questionnaires, consent forms, or third-party oral translation services)
- Those who cannot read due to visual impairment and cannot provide an impartial witness to support informed consent or study survey questionnaires
- Those with a hearing impairment and cannot provide an impartial witness to support informed consent
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Various Locations
Beverly Hills, California, 90211
Various Locations
Chino Hills, California, 91709
Various Locations
Irvine, California, 92604
Various Locations
Los Gatos, California, 95032
Various Locations
New York, New York, 10075
About this study
The Ezra Faster Scan study uses non-invasive magnetic resonance imaging (MRI) technology that can "visually" detect early and late-stage cancer, and other pathologies. MRIs use a magnetic field and radio waves to create a 3-dimensional (3D) image of an individual's body without using ionizing radiation.
The purpose of this research is to decrease the amount of time required by an individual to complete an early cancer screening comprehensive magnetic resonance imaging (MRI) scan, such as the Ezra Full Body MRI imaging scan. If the time required to conduct a comprehensive scan is reduced, the cost of the scan may also decrease. By decreasing consumer costs and time, more individuals may be able to afford MRI-based early cancer screening technology.
Read more
Participants in this study will undergo a minimum 30-minute MRI session. These sessions will be used to evaluate new MRI "instructions" that allow for a faster MRI scan time. The images will also be used to develop mathematical models or machine learning tools that allow images to be enhanced. By enhancing images using machine learning, they may be restored to a quality typically observed in MRI sessions with longer scan (acquisition) times.
To read more about the study, potential participants may review the informed consent form located below in the References section. Potential participants may email research.fasterscan@ezra.com, or call 516.340.1221.
See study Eligibility Criteria below.
- Conditions
- Medical Oncology, Cancer, Healthy
- Being tested
- Magnetic Resonance Imaging
- Keywords
- Magnetic Resonance Imaging, Early Cancer Detection, Machine Learning
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingOther
Also called MRI
Participants are required to undergo a non-invasive magnetic resonance imaging (MRI) scan approximately 30 minutes in length.
| Study group | Role | What they receive |
|---|---|---|
| Observational | The observational group may include those 18 years and older, with retrospective MRI data, or those whom prospective MRI images are collected as a participant. This study is decentralized, non-therapeutic and non-interventional. Receives: Other: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accelerated MRI Sequence Protocol Time (s)
The MRI scan time (minutes, seconds) for MRI instructions or sequences to be completed and qualitative feedback from MRI technologists and radiologists on execution of instrument instructions.
Measured: Approximately 30 minutes for each participant scan . Additional computational analysis of images throughout the study duration.
Statistical Analysis of MRI Images (Accelerated)
Computed image signal-to-noise and contrast-to-noise ratios of machine learning-restored accelerated images relative to accelerated images.
Measured: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
Statistical Analysis of MRI Images (Reference)
Computed image signal-to-noise and contrast-to-noise ratios of machine learning-restored accelerated images relative to reference images.
Measured: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
Statistical Analysis of MRI Images (Likert)
Visual radiologist review of reference and machine learning restored images. Images are reviewed using a Likert scale, comparing a reference image to a machine learning restored image. The scale grades are a radiologist's objective opinion of whether a machine learning restored image is similar to a reference image. If the machine learning image is worse, the radiologist rates the image strongly disagree or -2, if the machine learning image is better than the reference image, the radiologist selects strongly agree or 2. The Likert scale extends from worse to improved in the following order; strongly disagree (worse) -2, disagree -1, neither agree or disagree (neutral) 0, agree 1, or strongly agree 2. The minimum value is -2 and the maximum value is 2. A higher score greater than 0 indicates a better image, a lower score less than 0 indicates a worse image or outcome.
Measured: Approximately 10 minutes of a radiologist's time. Additional analysis of images throughout the study duration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jun 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medical OncologyStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 694 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ezra AI, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David Girard, Principal investigator, Ezra AI, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05385718
- Sponsor's protocol ID
- Ezra_002
- Acronym
- FasterScan
- Status last verified
- Sep 2024
- First submitted
- 17 May 2022
- Last updated
- 3 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified data may be shared for the purpose of research. Algorithms based on research may be commercialized or published.
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ezra Faster Scan Study
- ClinicalTrials.gov ID
- NCT05385718
- Acronym / sponsor ID
- FasterScan / Ezra_002
- Conditions
- Medical Oncology, Cancer, Healthy
- Keywords
- Magnetic Resonance Imaging, Early Cancer Detection, Machine Learning
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 694 participants (actual)
- Lead sponsor
- Ezra AI, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 23 May 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.
The Ezra Faster Scan study uses non-invasive magnetic resonance imaging (MRI) technology that can "visually" detect early and late-stage cancer, and other pathologies. MRIs use a magnetic field and radio waves to create a 3-dimensional (3D) image of an individual's body without using ionizing radiation.
The purpose of this research is to decrease the amount of time required by an individual to complete an early cancer screening comprehensive magnetic resonance imaging (MRI) scan, such as the Ezra Full Body MRI imaging scan. If the time required to conduct a comprehensive scan is reduced, the cost of the scan may also decrease. By decreasing consumer costs and time, more individuals may be able to afford MRI-based early cancer screening technology.
Participants in this study will undergo a minimum 30-minute MRI session. These sessions will be used to evaluate new MRI "instructions" that allow for a faster MRI scan time. The images will also be used to develop mathematical models or machine learning tools that allow images to be enhanced. By enhancing images using machine learning, they may be restored to a quality typically observed in MRI sessions with longer scan (acquisition) times.
To read more about the study, potential participants may review the informed consent form located below in the References section. Potential participants may email research.fasterscan@ezra.com, or call 516.340.1221.
See study Eligibility Criteria below.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Magnetic Resonance ImagingThe observational group may include those 18 years and older, with retrospective MRI data, or those whom prospective MRI images are collected as a participant. This study is decentralized, non-therapeutic and non-interventional. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants may be from the general public and located or able to travel to MRI facilities located in New York, New York; Queens, New York; Brooklyn, New York; Great Neck, New York; Irvine, California; Sunnyvale, California; Walnut Creek, California; San Francisco, California; Miami, Florida; Aventura, Florida. Participants may also be those who have accessed Ezra commercial MRI services in the past, or have scheduled commercial MRI services pending.
Key inclusion criteria (3 listed)
- Ability to provide legal informed consent and 18 years of age or older
- Resident of the contiguous United States and located within proximity of a designated research MRI facility
- Ability to travel to designated research MRI facilities
Key exclusion criteria (24 listed)
- Unable to receive an MRI due to existing implanted medical devices that may be disrupted by magnetic field or metal components/fragments that may migrate due to magnetic fields (pacemaker or defibrillator, stimulators, or stimulator wires (pacing leads), non-removeable metal dentures/braces/wires, surgical clips, (drug) pumps. Note metallic dental crowns or fillings are permitted.
- Those with orbital (eye socket) trauma caused by a metallic object
- Those with metallic fragments within the eye (foundry workers)
- Those with implanted cardiac pacemakers, implantable cardioverter defibrillators (ICDs), or diaphragmatic pacemakers, cardiac resynchronization therapy devices, implantable cardiovascular monitors, implantable loop recorders, neurostimulators
- Those with intra-cranial vascular clips (aneurysm), or prosthetic heart valve
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 |
|---|---|---|
| Magnetic Resonance ImagingAlso: MRIParticipants are required to undergo a non-invasive magnetic resonance imaging (MRI) scan approximately 30 minutes in length. | Other | Observational |
Primary outcome
Accelerated MRI Sequence Protocol Time (s)
Time frame: Approximately 30 minutes for each participant scan . Additional computational analysis of images throughout the study duration.
The MRI scan time (minutes, seconds) for MRI instructions or sequences to be completed and qualitative feedback from MRI technologists and radiologists on execution of instrument instructions.
Statistical Analysis of MRI Images (Accelerated)
Time frame: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
Computed image signal-to-noise and contrast-to-noise ratios of machine learning-restored accelerated images relative to accelerated images.
Statistical Analysis of MRI Images (Reference)
Time frame: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
Computed image signal-to-noise and contrast-to-noise ratios of machine learning-restored accelerated images relative to reference images.
Statistical Analysis of MRI Images (Likert)
Time frame: Approximately 10 minutes of a radiologist's time. Additional analysis of images throughout the study duration.
Visual radiologist review of reference and machine learning restored images. Images are reviewed using a Likert scale, comparing a reference image to a machine learning restored image. The scale grades are a radiologist's objective opinion of whether a machine learning restored image is similar to a reference image. If the machine learning image is worse, the radiologist rates the image strongly disagree or -2, if the machine learning image is better than the reference image, the radiologist selects strongly agree or 2. The Likert scale extends from worse to improved in the following order; strongly disagree (worse) -2, disagree -1, neither agree or disagree (neutral) 0, agree 1, or strongly agree 2. The minimum value is -2 and the maximum value is 2. A higher score greater than 0 indicates a better image, a lower score less than 0 indicates a worse image or outcome.
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 3 Mar 2025.
- Individual participant dataSharing planned: No. Deidentified data may be shared for the purpose of research. Algorithms based on research may be commercialized or published.
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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.
David Girard principal investigator
Ezra AI, Inc.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Medical Oncology and Cancer, run by Ezra AI, Inc. at 5 sites 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 3 inclusion and 24 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 3 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
Accelerated MRI Sequence Protocol Time (s) (time frame: Approximately 30 minutes for each participant scan . Additional computational analysis of images throughout the study duration.). The study lists 4 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 3 Mar 2025.