Try our beta test site

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by Real Imaging Ltd.
Information provided by (Responsible Party):
Real Imaging Ltd. Identifier:
First received: December 7, 2013
Last updated: September 1, 2016
Last verified: September 2016

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.

Breast Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Real Imaging Ltd.:

Primary Outcome Measures:
  • Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer [ Time Frame: up to 36 months ]

Secondary Outcome Measures:
  • To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer. [ Time Frame: up to 36 months ]

Estimated Enrollment: 300
Study Start Date: April 2014
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Women at high risk for breast cancer


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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)

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 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 up to 5 years preceding the study
  • 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 6 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02009150

Hadassah Medical Organization Not yet recruiting
Jerusalem, Israel, 91120
Contact: Tamar Sela, MD   
Sheba Medical Center Recruiting
Ramat-Gan, Israel, 52621
Contact: Miri Sklair-Levy, MD   
Sponsors and Collaborators
Real Imaging Ltd.
  More Information

Responsible Party: Real Imaging Ltd. Identifier: NCT02009150     History of Changes
Other Study ID Numbers: 960-CSP-ISR_HighRiskMC_ILS1 
Study First Received: December 7, 2013
Last Updated: September 1, 2016

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on February 20, 2017