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

NCT02777164 | Terminated DMC

• 1 other identifier: 960-CSP-USA_MIRA_USS2
• Study Type: interventional
• Target: 740
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone.

  19 months

Study Arms (1)

MIRA device imaging

EXPERIMENTAL

MIRA Device imaging for adjunctive detection of breast cancer

Device: MIRA device imaging

Interventions

MIRA device imaging DEVICE

MIRA Device imaging for adjunctive detection of breast cancer

Also known as: Real Imager 8

MIRA device imaging

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

MemorialCare Breast Center, Saddleback Memorial

Laguna Hills, California, 92653, United States

Location

Related Links

• Sponsor's Web site

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• David Izhaky

  Real Imaging Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: May 1, 2016
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: May 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)