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

Not Applicable

• Conditions: Breast Cancer

• Registration Number: NCT02155075
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-01
• Study First Submitted QC: 2014-06-03
• Study First Posted: 2014-06-04
• Study Start: 2015-01
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-17
• Last Update Posted: 2018-06-19
• Primary Completion: 2019-10
• Study Completion: 2019-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 730

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Sufficient number of cancer case and controls have been imaged	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.

Trial Locations

Locations (1)

The Chaim Sheba Medical Center at Tel Hashomer; 🇮🇱 Ramat-Gan, Israel