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

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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.

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.

Condition or disease
Breast Cancer

Study Type : Observational
Actual Enrollment : 575 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Collection of Raw Data of Thermal Imaging for the Purpose of Developing a Device for Early Detection of Breast Cancer
Study Start Date : November 2008
Actual Study Completion Date : August 2009

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00750464


Locations
Israel
Carmel Medical Center - Lin
Haifa, Israel
Hadassah Medical Organization
Jerusalem, Israel
Meir Medical Center
Kfar Saba, Israel
Rabin Medical Center
Petah Tikva, Israel
Sponsors and Collaborators
Real Imaging Ltd.
Investigators
Principal Investigator: Miri Sklair-Levy, MD Hadassah Medical Organization, Jerusalem

Responsible Party: Mr. Boaz Arnon, CEO, Real Imaging Ltd.
ClinicalTrials.gov Identifier: NCT00750464     History of Changes
Other Study ID Numbers: Pr-118-8061 ver. 001
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: October 14, 2009
Last Verified: October 2009

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases