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

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ClinicalTrials.gov Identifier: NCT02777164
Recruitment Status : Recruiting
First Posted : May 19, 2016
Last Update Posted : April 11, 2018
Sponsor:
Information provided by (Responsible Party):
Real Imaging Ltd.

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: MIRA device imaging Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System for Classifying Women at High Risk of Breast Cancer
Actual Study Start Date : May 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018

Resource links provided by the National Library of Medicine


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 Name: Real Imager 8




Primary Outcome Measures :
  1. The difference in the area under the ROC curve (AUC) of mammography plus MIRA compared to mammography alone. [ Time Frame: 19 months ]


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Ages Eligible for Study:   30 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

  1. Male by birth.
  2. Individual is less than 30 and greater than 70 years old.
  3. Contraindication to bilateral mammography or MRI
  4. Subjects who are unable to read, understand and execute the informed consent procedure.
  5. Subjects who have had mammography ultrasound or MRI examination performed on the day of the study prior to MIRA scan.
  6. Subjects who have significant existing breast trauma.
  7. Subjects who have undergone lumpectomy/mastectomy.
  8. Subjects who have undergone breast reduction or breast augmentation.
  9. Subjects who have undergone any other type of breast surgery, excluding surgical biopsy.
  10. Subjects who have large breast scar / Breast deformation
  11. 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.
  12. Subjects who have a temperature > 100° F (37.8C) degrees on the day of the MIRA imaging
  13. Subjects who are pregnant or lactating
  14. Subjects with known Raynaud's Disease
  15. Subjects that are claustrophobic or have physical limitations that do allow them to sit in the system chair for the required imaging session.
  16. Subjects with implanted pacemaker/defibrillator, implanted venous access device (portacath) or other implanted devices
  17. Subject with kidney failure
  18. Subject with known allergy to gadolinium
  19. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the past two year)
  20. Inmates (45 CFR 46.306) or mentally disabled individuals
  21. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the purpose of planning cancer therapy)
  22. Subjects currently participating in another investigational clinical study
  23. Subjects who participated in the Calibration Phase will not be able to participate in the Testing Phase

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777164


Contacts
Contact: David Izhaky +972-3-972-0602 David@realimaging.com

Locations
United States, California
MemorialCare Breast Center, Saddleback Memorial Recruiting
Laguna Hills, California, United States, 92653
Contact: Julie Ayala    949-452-7356    JAyala@memorialcare.org   
Contact: Erin O'Carroll-Godinez    (949) 452-7259    EOCarrollGodinez@memorialcare.org   
Principal Investigator: Gary Levine, MD         
Sponsors and Collaborators
Real Imaging Ltd.
Investigators
Study Director: David Izhaky Real Imaging Ltd.

Additional Information:
Responsible Party: Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT02777164     History of Changes
Other Study ID Numbers: 960-CSP-USA_MIRA_USS2
First Posted: May 19, 2016    Key Record Dates
Last Update Posted: April 11, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases