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

Status:	Recruiting
Conditions:	Breast Cancer, Cancer
Therapuetic Areas:	Oncology
Healthy:	No
Age Range:	40 - 70
Updated:	9/7/2018
Start Date:	April 15, 2018
End Date:	March 1, 2020
Contact:	Erin O'Carroll-Godinez
Email:	Erin@realimaging.com
Phone:	(949) 312-7992

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.

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

We found this trial at

sites

Jackson Clinic, PA

Jackson, Tennessee 38301

Principal Investigator: Stephen Hammond, MD

Phone: 731-664-1375

from

Jackson, TN