Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant.

All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI.

Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path.

MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result

MIRA device imaging

MIri Sklair-Levy, MD

Shelly Curtis

Miri Sklair-Levy, MD

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.

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

Evaluation of Real Imaging's 3d Functional Metabolic Imaging and Risk Assessment (Mira) System

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.

Real Imaging Ltd.

Breast Diseases

Skin Diseases

MIRA Device imaging for adjunctive detection of breast cancer

David Izhaky

The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.

Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

Francesco Sardanelli, M.D.

Francesco Sardanelli, M.D

The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.

Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer

Statistically significant increase of 30% or more in incremental cancer detection rate

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System	NCT02155075	Breast Cancer	MIRA device ima...	30 Years -	Real Imaging Ltd.
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer	NCT02777164	Breast Cancer	MIRA device ima...	30 Years - 70 Years	Real Imaging Ltd.
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer	NCT03296683	Breast Cancer	MIRA device ima...	24 Years -	Real Imaging Ltd.
Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System	NCT02155075	Breast Cancer	MIRA device ima...	30 Years -	Real Imaging Ltd.
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer	NCT03296683	Breast Cancer	MIRA device ima...	24 Years -	Real Imaging Ltd.

Spots Global Cancer Trial Database for mira device imaging