Back to results

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

Primary Purpose

Breast Cancer

Status

Unknown status

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

MIRA device imaging

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

30 Years - 79 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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:

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 MIRA scan.
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.
Subjects who have large breast scar / Breast deformation.
Subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study.
Subjects who have a temperature > 37.8C degrees on the day of the MIRA imaging.
Subjects who are pregnant or lactating.
Subjects who have had placement of an internal breast marker.
Subjects with known Raynaud's Disease.
Subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session.
Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices.
Inmates or mentally disabled individuals.
Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy).
Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase.
Subjects currently participating in another investigational clinical study.
Subjects undergoing breast MR for pre-staging.
Subjects with known Mastitis

Sites / Locations

BrustZentrumRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MIRA device imaging

Arm Description

MIRA Device imaging for adjunctive detection of breast cancer

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT03080155

First Posted

March 7, 2017

Last Updated

June 17, 2018

Sponsor

Real Imaging Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03080155

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2018

Overall Recruitment Status

Unknown status

Study Start Date

September 2016 (Actual)

Primary Completion Date

September 2018 (Anticipated)

Study Completion Date

October 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Real Imaging Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

680 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MIRA device imaging

Arm Type

Experimental

Arm Description

MIRA Device imaging for adjunctive detection of breast cancer

Intervention Type

Device

Intervention Name(s)

MIRA device imaging

Other Intervention Name(s)

Real Imager 8

Intervention Description

MIRA Device imaging for adjunctive detection of breast cancer

Primary Outcome Measure Information:

Title

determining MIRA's PPV (positive predictive value)

Description

Time Frame

24 months

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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: 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 MIRA scan. 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. Subjects who have large breast scar / Breast deformation. Subjects who have undergone a breast needle biopsy within the 6-month period prior to their intended enrollment into the study. Subjects who have a temperature > 37.8C degrees on the day of the MIRA imaging. Subjects who are pregnant or lactating. Subjects who have had placement of an internal breast marker. Subjects with known Raynaud's Disease. Subjects that are claustrophobic or have physical limitations that do not allow them to sit in the system chair for the required imaging session. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices. Inmates or mentally disabled individuals. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy). Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase. Subjects currently participating in another investigational clinical study. Subjects undergoing breast MR for pre-staging. Subjects with known Mastitis

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

David Izhaky

Phone

+972-3-972-0602

David@realimaging.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Uwe Fischer, Prof.

Organizational Affiliation

BrustZentrum, Göttingen

Official's Role

Principal Investigator

Facility Information:

Facility Name

BrustZentrum

City

Göttingen

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Uwe Fischer, Prof.

Phone

0551-82 074 0

info@brustzentrum-goettingen.de

Phone

0551 820 742 72

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs