Imaging Modality Effects on the Multi-dimensional InfraRed Analysis (MIRA) Technology

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the effect of everyday practice modalities (mammography, US) on the MIRA technology.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Data Collection Study for the Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment

NCT02505698

Breast Cancer

WITHDRAWN

Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

NCT02009150

Breast Cancer

UNKNOWN

Magnetic Resonance Imaging in Radiotherapy for Breast Cancer

NCT05902507

Breast Cancer

SUSPENDED

Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

NCT01004666

Small Breast Lesions Dense Breast Tissue Discrepancy With Clinical Examination +1 more

UNKNOWN

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

NCT02777164

Breast Cancer

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The objective of the current clinical study is to collect sufficient MIRA imaging data of subjects arriving for a routine screening mammography, before and after they undergo the mammography. This is in order to reach a conclusion whether the the firm breast compression involved in the mammography procedure affects the performance of the MIRA technology. At the current stage of the development of the device, the goal of this clinical trial is in no way to arrive at a statistical analysis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Gender: female
* Age: 50 years and older
* Subjects summoned for a routine screening mammography, ultrasound, diagnostic mammography or breast biopsy.
* Subject who have signed an informed consent form.

Exclusion Criteria

* Subjects who have had a mammography, ultrasound, and/or MRI examination performed on the day of the study, PRIOR to their FIRST imaging session with the RealImager.
* Subjects who have undergone any type of breast surgery throughout the 6 weeks preceding the study.
* Subjects who have had a breast biopsy performed throughout the 6 weeks preceding the study.
* Subjects who have undergone a mastectomy.
* Subjects who have undergone a lumpectomy.
* Subjects who have a large scar (causing breast deformation).
* Subjects who have previously undergone or are currently undergoing breast radiation therapy.
* Subjects who have previously undergone or are currently undergoing chemotherapy.
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who are pregnant.
* Subjects who are breast-feeding.

Minimum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes