A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts

NCT03288792 | Terminated FDA Device

• 1 other identifier: 960-CSP-USA_DenseBreasts_USS1
• Study Type: interventional
• Target: 435
• Locations: 1 country
• Sites: 5

Brief Summary

The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system used in conjunction with a conventional mammography to mammography alone, and to determine whether the addition of supplementary RI8 result will improve ROC area under the curve. The study is prospective, multi-center, sequential, control trial with the woman serving as her own control. Women determined to have heterogeneously or extremely dense breast based on her previous mammogram and are undergoing routine screening mammography at one of the clinical sites assigned for this study will be eligible to join the study.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (2)

• Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone.

  18 months

• All adverse events and serious adverse events caused by the imaging session as judged by the physician.

  18 months

Secondary Outcomes (1)

• Sensitivity and specificity will be computed based on the forced BI-RADS assessment of each mammography case alone and mammography plus RI8.

  18 months

Other Outcomes (1)

• Sensitivity and specificity of the device will be determined from all enrolled cases. Upper and lower estimates will be determined based on missing data.

  18 months

Study Arms (1)

RI8 device imaging

EXPERIMENTAL

RI8 Device imaging for adjunctive detection of breast cancer

Device: RI8 device imaging

Interventions

RI8 device imaging DEVICE

RI8 Device imaging for adjunctive detection of breast cancer

Also known as: Real Imager 8

RI8 device imaging

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A. Subjects whose most recent (within 18 months) prior mammogram interpreted as heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast Density D) breast tissue.
• AND
• B. Subjects who are asymptomatic and scheduled to undergo routine screening mammography.
• C. Subjects scheduled for image-guided needle biopsy as a result of findings obtained during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed at the clinical site that participates in the study.

You may not qualify if:

• Male by birth.
• Individual is less than 40 and greater than 70 years old.
• Contraindication to bilateral mammography or MRI.
• Subjects who are unable to read, understand and execute the informed consent procedure.
• Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to RI8 scan.
• Subjects who are pre-menopausal and are between the 14th and 28th day after the start of the menstrual cycle
• Subjects who have significant existing breast trauma.
• Subjects who have undergone lumpectomy/mastectomy.
• Subjects who have undergone breast reduction or breast augmentation.
• Subjects who have undergone any other type of breast surgery, including surgical biopsy.
• Subjects who have large breast scar / breast deformation
• Subjects who have undergone a breast needle biopsy within the 6-week period prior to their intended enrollment into the study.
• Subjects who have a temperature \> 100° F (37.8C) degrees on the day of the RI8 imaging.
• Subjects who are pregnant or lactating.
• Subjects with known Raynaud's Disease.

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (5)

Saddleback MemorialCare Breast Center

Laguna Hills, California, 92653, United States

Location

Memorial Healthcare System

Hollywood, Florida, 33021, United States

Location

Doris Shaheen Breast Health Center Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

The Jackson Clinic

Jackson, Tennessee, 38305, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Sponsor's Web site

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2017
• First Posted: September 20, 2017
• Study Start: April 15, 2018
• Primary Completion: April 9, 2019
• Study Completion: April 30, 2019
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)