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


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

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


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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Principal Investigator

Miri Sklair-Levy, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hadassah Medical Organization, Jerusalem

Authority:

Israel: Ministry of Health

Study ID:

Pr-118-8061 ver. 001

NCT ID:

NCT00750464

Start Date:

November 2008

Completion Date:

August 2009

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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