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

NCT02009150 | Unknown

• 1 other identifier: 960-CSP-ISR_HighRiskMC_ILS1
• Study Type: observational
• Target: 236
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer

  up to 36 months

Secondary Outcomes (1)

• To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.

  up to 36 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

The Chaim Sheba Medical Center at Tel-Hashomer

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Miri Sklair-Levy, MD

  The Chaim Sheba Medical center at Tel-Hashomer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2013
• First Posted: December 11, 2013
• Study Start: April 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: October 1, 2018
• Last Updated: September 5, 2018

Record last verified: 2018-09

Locations

IL (1)