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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
  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 ("RI3.0") capabilities , which will assist in early detection of breast cancer.


Condition
Breast Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Real Imaging Ltd.:

Enrollment: 575
Study Start Date: November 2008
Study Completion Date: August 2009
  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:

  • 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: September 9, 2008
Last Updated: October 12, 2009
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on May 22, 2013