Evaluation of Real Imaging's 3D Functional Metabolic Imaging and Risk Assessment (MIRA) System

NCT02155075 | Unknown

• 1 other identifier: 960-CSP-ISR_ImplantsMC_ILS3
• Study Type: interventional
• Target: 730
• Locations: 1 country
• Sites: 1

Brief Summary

Three-dimensional functional Metabolic Imaging (3D MIRA) is a new infrared imaging technology using the Real Imager 8 (RI8) developed by Real Imaging. This technology generates 3D metabolic maps of the breast and based on sophisticated machine learning technology, provides objective risk assessment for the presence of malignant tumor in the breast. The procedure is non-invasive, comfortable and does not involve ionizing radiation. It is based on acquiring infrared images of the breast. Those images are processed and analyzed by computers to provide the objective risk assessment. The technology is intended to be used as a screening tool for breast cancer and emerges as highly useful in women for whom screening mammography is sub-optimal, such as women with dense breast. 3D 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 breast cancer in women.

Conditions

Breast Cancer

Keywords

Breast neoplasm; Breast implants; Mammography; Breast imaging; Imaging augmented breast

Outcome Measures

Primary Outcomes (1)

• Sufficient number of cancer case and controls have been imaged

  As this is a data collection study, end point will be reached when approximately 50 women with breast cancer and 100 healthy women (controls) are imaged by the device and sufficient for the comparison statistical analysis.

  up to 24 months

Study Arms (2)

Arm 1

EXPERIMENTAL

Testing phase (Phase II) Arm 1 - 180 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure, the optimized risk model will assign a binary result to the participant. All participants will recive standart of care, participants with negative screening exams and a positive MIRA device imaging result will additionally undergo MRI.

Device: MIRA device imaging

Arm 2

EXPERIMENTAL

Testing phase (Phase II) Arm 2 - 150 participant will be enrolled for this arm. Participants will be enrolled to undergo MIRA device imaging. Following the MIRA device imaging procedure all participants in arm 2 will be following standard of care, MIRA device imaging will NOT change their clinical path.

Device: MIRA device imaging

Interventions

MIRA device imaging DEVICE

MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result

Also known as: Real imager 8 (RI8)

Arm 1; Arm 2

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• Woman has read, understood and signed the inform consent form
• Age: 30 years and older
• A. Women who are scheduled to undergo routine Mammography and/or US and/or MRI screening OR B. Women summoned for breast biopsy following a suspicious finding in recent screening exam and was graded 4/5 on BI-RADS scale

You may not qualify if:

• Women who have had a Mammography and/or US and/or MRI examination performed on the day of the study prior to MIRA scan
• Women who had undergone mastectomy and/or breast reconstruction
• 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 with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices in the chest area
• Women who are unable to read, understand and execute written informed consent
• Women who are currently undergoing chemotherapy and/or radiotherapy
• PHASE 2:
• ARM 1:
• Female
• Age: 30 years and older
• A. Asymptomatic women who are scheduled to undergo routine screening mammography or routine screening mammography and US Or B. Subjects scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI).
• \. Women whose most recent prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D).

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

The Chaim Sheba Medical Center at Tel Hashomer

Ramat Gan, 5262000, Israel

RECRUITING

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

Central Study Contacts

MIri Sklair-Levy, MD

CONTACT

972-3-5302514; Miri.SklairLevy@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2014
• First Posted: June 4, 2014
• Study Start: January 1, 2015
• Primary Completion: October 1, 2019
• Study Completion: October 1, 2019
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

IL (1)