Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

NCT ID: NCT02009150

Last Updated: 2018-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 236 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2018-10-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Real Imaging Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Miri Sklair-Levy, MD

Role: PRINCIPAL_INVESTIGATOR

The Chaim Sheba Medical center at Tel-Hashomer

Locations

The Chaim Sheba Medical Center at Tel-Hashomer

Ramat Gan, , Israel

Countries

Israel

Other Identifiers

960-CSP-ISR_HighRiskMC_ILS1

Identifier Type: -

Identifier Source: org_study_id