Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02155075
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : April 11, 2018
Information provided by (Responsible Party):
Real Imaging Ltd.

Brief Summary:

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment.

The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D MIRA is unaffected by breast density and is therefore ideal for evaluating patients with mammographically dense breasts.

The purpose of this clinical study is to assess the ability of this novel technology to detect breast cancer in women.

Condition or disease
Breast Cancer

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System
Actual Study Start Date : January 2015
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Primary Outcome Measures :
  1. Sufficient number of cancer case and controls have been imaged [ Time Frame: up to 24 months ]
    As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Women aged 30 years and older, who regardless of this clinical trial are summoned for routine breast cancer screening exam or breast biopsy due to suspicious finding in recent screening exam.

Inclusion Criteria:

  • Female
  • Woman has read, understood and signed the inform consent form
  • Age: 30 years and older
  • Women who are scheduled to undergo routine Mx and/or US and/or MRI screening OR Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale

Exclusion Criteria:

  • Women who have had a Mx and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
  • Women who had undergone mastectomy and/or breast reconstruction
  • Women who have had a breast biopsy performed throughout the 6 weeks preceding the study
  • Women who have a fever on the day of the MIRA imaging
  • Women who are pregnant
  • Women who are breast-feeding
  • Women with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
  • Women who are unable to read, understand and execute written informed consent
  • Women who are currently undergoing chemotherapy and/or radiotherapy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02155075

Contact: MIri Sklair-Levy, MD 972-3-5302514

The Chaim Sheba Medical Center at Tel Hashomer Recruiting
Ramat-Gan, Israel, 5262000
Contact: Shelly Curtis    972-50-722-4421   
Principal Investigator: Miri Sklair-Levy, MD         
Sponsors and Collaborators
Real Imaging Ltd.
Principal Investigator: Miri Sklair-Levy, MD The Chaim Sheba Medical center at Tel-Hashomer

Responsible Party: Real Imaging Ltd. Identifier: NCT02155075     History of Changes
Other Study ID Numbers: 960-CSP-ISR_ImplantsMC_ILS3
First Posted: June 4, 2014    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: September 2017

Keywords provided by Real Imaging Ltd.:
Breast neoplasm
Breast implants
Breast imaging
Imaging augmented breast