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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00750464
• Other study ID #: Pr-118-8061 ver. 001
• Status: Completed
• Phase: N/A
• First received: September 9, 2008
• Last updated: October 12, 2009
• Start date: November 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2009
• Source: Real Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 575
• Est. completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	Carmel Medical Center - Lin	Haifa
Israel	Hadassah Medical Organization	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Real Imaging Ltd.

Country where clinical trial is conducted

Israel,