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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00750464
Recruitment Status : Completed
First Posted : September 10, 2008
Last Update Posted : October 14, 2009
Sponsor:
Information provided by:
Real Imaging Ltd.

Tracking Information
First Submitted Date September 9, 2008
First Posted Date September 10, 2008
Last Update Posted Date October 14, 2009
Study Start Date November 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Official Title 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 in order to evaluate and improve Real Imaging's device ("RI3.0") capabilities , which will assist in early detection of breast cancer.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
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) requiring a biopsy
Condition Breast Cancer
Intervention Not Provided
Study Groups/Cohorts 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 Completed
Actual Enrollment
 (submitted: October 12, 2009)
575
Original Estimated Enrollment
 (submitted: September 9, 2008)
1000
Actual Study Completion Date August 2009
Primary Completion Date Not Provided
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00750464
Other Study ID Numbers Pr-118-8061 ver. 001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Mr. Boaz Arnon, CEO, Real Imaging Ltd.
Study Sponsor Real Imaging Ltd.
Collaborators Not Provided
Investigators
Principal Investigator: Miri Sklair-Levy, MD Hadassah Medical Organization, Jerusalem
PRS Account Real Imaging Ltd.
Verification Date October 2009