Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer

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

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Recruitment Status

COMPLETED

Total Enrollment

1827 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2012-02-29

Brief Summary

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Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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Inclusion Criteria

* Gender: female
* Age: 18 years and older
* Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.
* 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 being "imaged" by RI4.0.
* 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 a large scar (causing breast deformation) following breast lumpectomy and/or any other cause (e.g. accident).
* Subjects with prior breast reduction surgery or breast augmentation surgery.
* Subjects who have a fever on the day of their biopsy.
* Subjects who are pregnant.
* Subjects who are breast-feeding.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes