Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System
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|ClinicalTrials.gov Identifier: NCT02155075|
Recruitment Status : Recruiting
First Posted : June 4, 2014
Last Update Posted : April 11, 2018
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|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02155075
|Contact: MIri Sklair-Levy, MD||972-3-5302514||Miri.SklairLevy@sheba.health.gov.il|
|The Chaim Sheba Medical Center at Tel Hashomer||Recruiting|
|Ramat-Gan, Israel, 5262000|
|Contact: Shelly Curtis 972-50-722-4421 Shelly@realimaging.com|
|Principal Investigator: Miri Sklair-Levy, MD|
|Principal Investigator:||Miri Sklair-Levy, MD||The Chaim Sheba Medical center at Tel-Hashomer|