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

A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts

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.

Study Overview

• Status: Terminated
• Conditions: Breast Cancer
• Intervention / Treatment: Device: RI8 device imaging

• Study Type: Interventional
• Enrollment (Actual): 435
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Laguna Hills, California, United States, 92653
      • Saddleback MemorialCare Breast Center
  • Florida
    • Hollywood, Florida, United States, 33021
      • Memorial Healthcare System
  • Georgia
    • Atlanta, Georgia, United States, 30309
      • Doris Shaheen Breast Health Center Piedmont Hospital
  • Tennessee
    • Jackson, Tennessee, United States, 38305
      • The Jackson Clinic
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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.

OR

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.

Exclusion Criteria:

1. Male by birth.
2. Individual is less than 40 and greater than 70 years old.
3. Contraindication to bilateral mammography or MRI.
4. Subjects who are unable to read, understand and execute the informed consent procedure.
5. Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to RI8 scan.
6. Subjects who are pre-menopausal and are between the 14th and 28th day after the start of the menstrual cycle
7. Subjects who have significant existing breast trauma.
8. Subjects who have undergone lumpectomy/mastectomy.
9. Subjects who have undergone breast reduction or breast augmentation.
10. Subjects who have undergone any other type of breast surgery, including surgical biopsy.
11. Subjects who have large breast scar / breast deformation
12. Subjects who have undergone a breast needle biopsy within the 6-week period prior to their intended enrollment into the study.
13. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the RI8 imaging.
14. Subjects who are pregnant or lactating.
15. Subjects with known Raynaud's Disease.
16. Subjects with known Mastitis.
17. Subjects diagnosed with epileptic seizures.
18. Subjects with weight > 135kg (~300 Lbs.).
19. Subjects who are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
20. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
21. Subject with kidney failure
22. Subject with known allergy to gadolinium
23. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
24. Inmates (45 CFR 46.306) or mentally disabled individuals.
25. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
26. Subjects currently participating in another investigational clinical study.
27. Subject scheduled for a biopsy due to suspicious symptomatic lump
28. Subjects who participated in the Validation Phase will not be able to participate in the Testing Phase

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SCREENING
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RI8 device imaging; RI8 Device imaging for adjunctive detection of breast cancer	Device: RI8 device imaging; RI8 Device imaging for adjunctive detection of breast cancer; Other Names: Real Imager 8

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Real Imaging Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2018
• Primary Completion (ACTUAL): April 9, 2019
• Study Completion (ACTUAL): April 30, 2019

Study Registration Dates

• First Submitted: September 18, 2017
• First Submitted That Met QC Criteria: September 19, 2017
• First Posted (ACTUAL): September 20, 2017

Study Record Updates

• Last Update Posted (ACTUAL): May 3, 2019
• Last Update Submitted That Met QC Criteria: May 1, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 960-CSP-USA_DenseBreasts_USS1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No