Clinical trial NCT05385718: Ezra Faster Scan Study
Official title: Ezra Faster Scan Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Medical Oncology
Cancer
Healthy
Keywords: Magnetic Resonance Imaging
Early Cancer Detection
Machine Learning
Lead sponsor: Ezra AI, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-23
Enrollment: 694
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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

Primary outcomes:
measure: Accelerated MRI Sequence Protocol Time (s)
timeFrame: Approximately 30 minutes for each participant scan . Additional computational analysis of images throughout the study duration.
measure: Statistical Analysis of MRI Images (Accelerated)
timeFrame: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
measure: Statistical Analysis of MRI Images (Reference)
timeFrame: Approximately 30 minutes for each participant scan. Additional computational analysis of images throughout the study duration.
measure: Statistical Analysis of MRI Images (Likert)
timeFrame: Approximately 10 minutes of a radiologist's time. Additional analysis of images throughout the study duration.
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Various Locations
state: California
city: Chino Hills
country: United States
facility: Various Locations
state: California
city: Irvine
country: United States
facility: Various Locations
state: California
city: Los Gatos
country: United States
facility: Various Locations
state: California
city: New York
country: United States
facility: Various Locations
state: New York
Study officials:
affiliation: Ezra AI, Inc.
name: David Girard
role: PRINCIPAL_INVESTIGATOR
References: