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

NCT03296683 | Unknown

• 1 other identifier: 960-CLP-ITL_RI8 _ITS1
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

Brief Summary

The study objective is to evaluate the added value of MIRA technology as an adjunct to mammography in the detection of malignant breast lesions in women with dense breast and/or at elevated risk of breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Increase in incremental cancer detection rate

  Statistically significant increase of 30% or more in incremental cancer detection rate

  24 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: 24 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \*\*Calibration Phase:
• 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 (mammography, ultrasound and/or MRI)
• \*\*Testing Phase:
• A. Subjects scheduled to undergo routine screening mammography and at least one of the following :
• Subjects whose most recent (within 3 years) prior mammogram was interpreted as heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS Breast Density 4).
• Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.

You may not qualify if:

• Male by birth.
• Individual is less than 24 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.
• 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 \> 100° F (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.

Sponsors & Collaborators

• Real Imaging Ltd.: lead

Study Sites (1)

Policlinico San Donato

San Donato Milanese, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Francesco Sardanelli, M.D

  Policlinico San Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David Izhaky

CONTACT

+972-3-972-0602; david@realimaging.com

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: September 18, 2017
• First Posted: September 28, 2017
• Study Start: May 23, 2017
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2021
• Last Updated: June 19, 2018

Record last verified: 2018-06

Locations

IT (1)