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

This study has been completed.
Sponsor:
Information provided by:
Real Imaging Ltd.
ClinicalTrials.gov Identifier:
NCT00750464
First received: September 9, 2008
Last updated: October 12, 2009
Last verified: October 2009
History of Changes

September 9, 2008
October 12, 2009
November 2008
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Complete list of historical versions of study NCT00750464 on ClinicalTrials.gov Archive Site
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Collection of Raw Data of Thermal Imaging 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

Collection of thermal "images" of women with breast tumors in varying degrees of severity in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Non-Probability Sample

Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) requiring a biopsy
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
575
August 2009
Not Provided

Inclusion Criteria:

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

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 RI3.0.
  • 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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00750464
Pr-118-8061 ver. 001
No
Mr. Boaz Arnon, CEO, Real Imaging Ltd.
Real Imaging Ltd.
Not Provided
Principal Investigator: Miri Sklair-Levy, MD Hadassah Medical Organization, Jerusalem
Real Imaging Ltd.
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP