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

NCT02777164 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 740

Last updated 2019-05-03

No results posted yet for this study

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

Interventions

DEVICE

MIRA device imaging

MIRA Device imaging for adjunctive detection of breast cancer

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Principal Investigators

  • David Izhaky · Real Imaging Ltd.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-31
Primary Completion
2017-10-31
Completion
2018-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02777164 on ClinicalTrials.gov