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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00821613

Enrollment

1827

Registered

2009-01-13

Start date

2009-09-30

Completion date

2012-02-29

Last updated

2012-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Countries

Israel

Outcome results