Back to resultsEvaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Primary Purpose
Breast Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIRA device imaging
Sponsored by
About this trial
This is an interventional screening trial for Breast Cancer
Eligibility Criteria
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:
- Male by birth.
- Individual is less than 30 and greater than 70 years old.
- 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, excluding surgical biopsy.
- Subjects who have large breast scar / Breast deformation
- 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.
- Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging
- Subjects who are pregnant or lactating
- Subjects with known Raynaud's Disease
- Subjects that are claustrophobic or have physical limitations that do 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
- Subject with kidney failure
- Subject with known allergy to gadolinium
- Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
- Inmates (45 CFR 46.306) 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 currently participating in another investigational clinical study
- Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
Sites / Locations
- MemorialCare Breast Center, Saddleback Memorial
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
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02777164
Brief Title
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Official Title
Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Terminated
Why Stopped
Sponsor decision, not safety related
Study Start Date
May 2016 (Actual)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
October 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Real Imaging Ltd.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
740 (Actual)
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
The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.
Time Frame
19 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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:
Male by birth.
Individual is less than 30 and greater than 70 years old.
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, excluding surgical biopsy.
Subjects who have large breast scar / Breast deformation
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.
Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging
Subjects who are pregnant or lactating
Subjects with known Raynaud's Disease
Subjects that are claustrophobic or have physical limitations that do 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
Subject with kidney failure
Subject with known allergy to gadolinium
Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
Inmates (45 CFR 46.306) 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 currently participating in another investigational clinical study
Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Izhaky
Organizational Affiliation
Real Imaging Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
MemorialCare Breast Center, Saddleback Memorial
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.realimaging.com/
Description
Sponsor's Web site
Learn more about this trial
Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
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