Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

Breast Cancer Clinical Trial

Official title:

Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02777164
• Other study ID #: 960-CSP-USA_MIRA_USS2
• Status: Terminated
• Phase: N/A
• Start date: May 2016
• Est. completion date: October 2018

Study information

• Verified date: May 2019
• Source: Real Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of the study is to estimate the diagnostic accuracy of cancer detection when MIRA technology is combined with mammography, by evaluating the area under the ROC curve (AUC) of mammography vs. mammography plus MIRA. This evaluation will be done in a Reader Study on a subset of women with histology confirmed cancer and healthy women with dense breast.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 740
• Est. completion date: October 2018
• Est. primary completion date: October 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

A. Subjects who are asymptomatic and scheduled to undergo routine screening mammography

OR

B. Subjects scheduled for image guided needle biopsy as a result of findings obtained during standard of care imaging modalities

AND

C. Subjects has a prior mammogram and have been diagnosed with extremely or heterogeneously dense breast tissue (Density C or D)

Exclusion Criteria:

1. Male by birth.

2. Individual is less than 30 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 MIRA scan.

6. Subjects who have significant existing breast trauma.

7. Subjects who have undergone lumpectomy/mastectomy.

8. Subjects who have undergone breast reduction or breast augmentation.

9. Subjects who have undergone any other type of breast surgery, excluding surgical biopsy.

10. Subjects who have large breast scar / Breast deformation

11. Subjects who have undergone a breast needle biopsy or a surgical biopsy within the 6 month period prior to their intended enrollment into the study.

12. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging

13. Subjects who are pregnant or lactating

14. Subjects with known Raynaud's Disease

15. Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.

16. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices

17. Subject with kidney failure

18. Subject with known allergy to gadolinium

19. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)

20. Inmates (45 CFR 46.306) or mentally disabled individuals

21. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy)

22. Subjects currently participating in another investigational clinical study

23. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• MIRA device imaging
MIRA Device imaging for adjunctive detection of breast cancer

Locations

Country	Name	City	State
United States	MemorialCare Breast Center, Saddleback Memorial	Laguna Hills	California

Sponsors (1)

Lead Sponsor	Collaborator
Real Imaging Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.		19 months

External Links

•   Sponsor's Web site