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

This study is not yet open for participant recruitment.

Verified by Real Imaging Ltd., January 2009

First Received: January 12, 2009 No Changes Posted

Sponsored by:	Real Imaging Ltd.
Information provided by:	Real Imaging Ltd.
ClinicalTrials.gov Identifier:	NCT00821613

Purpose

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RealImager4.0"), capabilities which will assist in early detection of breast cancer.

Condition
Breast Cancer

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only
Official Title:	Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer

Further study details as provided by Real Imaging Ltd.:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	300
Study Start Date:	March 2009
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy

Criteria

Inclusion Criteria:

Gender: female
Age: 18 years and older
Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination), requiring a 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 being "imaged" by 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 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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00821613

Locations

Israel
Sheba Medical Center
Ramat Gan, Israel

Sponsors and Collaborators

Real Imaging Ltd.

More Information

No publications provided

Responsible Party:	Real Imaging Ltd. ( Boaz Arnon )
Study ID Numbers:	960-PRL-09011
Study First Received:	January 12, 2009
Last Updated:	January 12, 2009
ClinicalTrials.gov Identifier:	NCT00821613 History of Changes
Health Authority:	Israel: Ethics Commission; Israel: Ministry of Health

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009