MedTrace Logo

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

NCT03080155 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 680

Last updated 2018-06-19

No results posted yet for this study

Summary

The purpose of the study is to assess the effectiveness of MIRA in classifying women with dense breast tissue for supplemental breast MRI. To assess the effectiveness of MIRA for correctly classifying women with breast cancer and to evaluate the safety of the device.

In women above 30 years old who are undergoing MRI or are scheduled for image-guided needle biopsy due to lesions detected by other imaging modalities.

Conditions

Interventions

DEVICE

MIRA device imaging

MIRA Device imaging for adjunctive detection of breast cancer

Sponsors & Collaborators

  • Real Imaging Ltd.

    lead INDUSTRY

Principal Investigators

  • Uwe Fischer, Prof. · BrustZentrum, Göttingen

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2018-09-30
Completion
2018-10-31

Countries

  • Germany

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 NCT03080155 on ClinicalTrials.gov