Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 4(RI4) developed by Real Imaging. This technology generates 3D metabolic maps and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor. The procedure is non-invasive, comfortable and does not involve ionizing radiation. Moreover, Real Imaging's 3D Functional 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 clinically occult breast cancer in a cohort of women that are at high risk for breast cancer.
We hypothesize that the combination of screening mammography and metabolic screening (3D MIRA) will result in significantly higher breast cancer detection rates.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women at high risk for breast cancer | Proven carriers of deleterious BRCA1 or BRCA2 mutations Or Women that were found to have a lifetime risk of developing breast cancer greater or equal to 20% based on Tyrer-Cuzick, Gail or Clause risk models. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer | up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer. | up to 36 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Women who are determined to have high risk of breast cancer and who are screened biannually by existing screening modalities (mammography, ultrasound or MRI)
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Miri Sklair-Levy, MD | The Chaim Sheba Medical center at Tel-Hashomer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Chaim Sheba Medical Center at Tel-Hashomer | Ramat Gan | 5262000 | Israel |
Not provided
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| D017437 |
| Skin and Connective Tissue Diseases |