Status:
TERMINATED
A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts
Lead Sponsor:
Real Imaging Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-70 years
Phase:
NA
Brief Summary
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 addi...
Eligibility Criteria
Inclusion
- 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
- Male by birth.
- Individual is less than 40 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 RI8 scan.
- Subjects who are pre-menopausal and are between the 14th and 28th day after the start of the menstrual cycle
- 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, including surgical biopsy.
- Subjects who have large breast scar / breast deformation
- Subjects who have undergone a breast needle biopsy within the 6-week period prior to their intended enrollment into the study.
- Subjects who have a temperature \> 100° F (37.8C) degrees on the day of the RI8 imaging.
- Subjects who are pregnant or lactating.
- Subjects with known Raynaud's Disease.
- Subjects with known Mastitis.
- Subjects diagnosed with epileptic seizures.
- Subjects with weight \> 135kg (\~300 Lbs.).
- Subjects who 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.
- 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.
- Subject scheduled for a biopsy due to suspicious symptomatic lump
- Subjects who participated in the Validation Phase will not be able to participate in the Testing Phase
Key Trial Info
Start Date :
April 15 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2019
Estimated Enrollment :
435 Patients enrolled
Trial Details
Trial ID
NCT03288792
Start Date
April 15 2018
End Date
April 30 2019
Last Update
May 3 2019
Active Locations (5)
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1
Saddleback MemorialCare Breast Center
Laguna Hills, California, United States, 92653
2
Memorial Healthcare System
Hollywood, Florida, United States, 33021
3
Doris Shaheen Breast Health Center Piedmont Hospital
Atlanta, Georgia, United States, 30309
4
The Jackson Clinic
Jackson, Tennessee, United States, 38305