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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Real Imaging Ltd.

ClinicalTrials.gov Identifier:

NCT00821613

First received: January 12, 2009

Last updated: February 7, 2012

Last verified: February 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	January 12, 2009
Last Updated Date	February 7, 2012
Start Date ^ICMJE	September 2009
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE	Not Provided
Original Primary Outcome Measures ^ICMJE	Not Provided
Change History	Complete list of historical versions of study NCT00821613 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Data Collection Study of Raw Thermal Images for the Purpose of Developing a Device for Early Detection of Breast Cancer
Official Title ^ICMJE	Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	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.
Condition ^ICMJE	Breast Cancer
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	1827
Completion Date	February 2012
Primary Completion Date	February 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Female
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Israel

Administrative Information
NCT Number ^ICMJE	NCT00821613
Other Study ID Numbers ^ICMJE	Pr-118-8061 ver. 004, QMS number: 960-PRL-09011
Has Data Monitoring Committee	No
Responsible Party	Real Imaging Ltd.
Study Sponsor ^ICMJE	Real Imaging Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Real Imaging Ltd.
Verification Date	February 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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