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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02009150
• Other study ID #: 960-CSP-ISR_HighRiskMC_ILS1
• Status: Active, not recruiting
• Start date: April 2014
• Est. completion date: October 2018

Study information

• Verified date: September 2018
• Source: Real Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 236
• Est. completion date: October 2018
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	The Chaim Sheba Medical Center at Tel-Hashomer	Ramat-Gan

Sponsors (1)

Lead Sponsor	Collaborator
Real Imaging Ltd.

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of 3D MIRA as a breast imaging aid in women with a high risk of breast cancer		up to 36 months
Secondary	To test whether repetitive screening with 3D MIRA technology can provide information on the likelihood of developing breast cancer.		up to 36 months