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

The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.

In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer
• Intervention / Treatment: Device: MIRA device imaging

• Study Type: Interventional
• Enrollment (Anticipated): 680
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Izhaky; Phone Number: +972-3-972-0602; Email: David@realimaging.com

Study Locations

• Germany
  • Göttingen, Germany
    • Recruiting
    • BrustZentrum
    • Contact: Uwe Fischer, Prof.; Phone Number: 0551-82 074 0; Email: info@brustzentrum-goettingen.de
    • Contact: Phone Number: 0551 820 742 72

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women who are between 30 to 70 years of age and who are asymptomatic and scheduled to undergo routine breast cancer screening (MRI and/or mammography) OR
• Women who are between 30 to 79 years of age and 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. Contraindication to bilateral mammography or MRI.
2. Subjects who are unable to read, understand and execute the informed consent procedure.
3. Subjects who have had mammography, ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
4. Subjects who have significant existing breast trauma.
5. Subjects who have undergone lumpectomy/mastectomy.
6. Subjects who have undergone breast reduction or breast augmentation.
7. Subjects who have undergone any other type of breast surgery.
8. Subjects who have large breast scar / Breast deformation.
9. Subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study.
10. Subjects who have a temperature > 37.8C degrees on the day of the MIRA imaging.
11. Subjects who are pregnant or lactating.
12. Subjects who have had placement of an internal breast marker.
13. Subjects with known Raynaud's Disease.
14. Subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
15. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
16. Inmates or mentally disabled individuals.
17. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
18. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
19. Subjects currently participating in another investigational clinical study.
20. Subjects undergoing breast MR for pre-staging.
21. Subjects with known Mastitis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
determining MIRA's PPV (positive predictive value)	The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using positive MRI (MRI BI-RADS >= 3) as a reference test in cohort of women with negative (Mammography BI-RADS 1 or 2).; The positive predictive value (and the amount of false-positive diagnoses) of MIRA will be determined using the histological diagnosis as the reference test in ALL women participated in the study.	24 months

Collaborators and Investigators

• Sponsor: Real Imaging Ltd.
• Investigators: Principal Investigator: Uwe Fischer, Prof., BrustZentrum, Göttingen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2016
• Primary Completion (Anticipated): September 1, 2018
• Study Completion (Anticipated): October 1, 2018

Study Registration Dates

• First Submitted: March 7, 2017
• First Submitted That Met QC Criteria: March 9, 2017
• First Posted (Actual): March 15, 2017

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 17, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 960-CLP-GER_Multimodality_GER1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No