Clinical trial NCT02009150: Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.
Official title: Evaluation of REAL IMAGING'S 3D Functional Metabolic Imaging and Risk Assessment ("3D MIRA") System in Women at High Risk for Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Real Imaging Ltd.
Sponsor class: INDUSTRY
First posted: 2013-12-11
Enrollment: 236
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who are determined to have high risk of breast cancer and who are screened biannually by existing screening modalities (mammography, ultrasound or MRI)

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Female
* Woman has read, understood and signed the inform consent form
* Age: 20 years and older
* Women who are asymptomatic 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
* Women scheduled to undergo routine mammography and/or US or MRI screening

Exclusion Criteria:

* Women who have had a mammography and/or ultrasound examination performed on the day of the study prior to MIRA scan
* Women who had a lumpectomy surgery
* Women who had undergone mastectomy and/or reconstruction
* Women who have undergone any type of breast surgery throughout the 6 months preceding the study
* Women who have had a breast biopsy performed throughout the 10 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 who had undergone breast reduction/augmentation

Primary outcomes:
measure: Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer
timeFrame: up to 36 months
Secondary outcomes:
measure: To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.
timeFrame: up to 36 months
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: The Chaim Sheba Medical Center at Tel-Hashomer
Study officials:
affiliation: The Chaim Sheba Medical center at Tel-Hashomer
name: Miri Sklair-Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: