Data Collection Study of Raw Thermal Images 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: NCT00821613
• Other study ID #: Pr-118-8061 ver. 004
• Secondary ID: QMS number: 960-
• Status: Completed
• Phase: N/A
• First received: January 12, 2009
• Last updated: February 7, 2012
• Start date: September 2009
• Est. completion date: February 2012

Study information

• Verified date: February 2012
• Source: Real Imaging Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics CommissionIsrael: Ministry of Health
• Study type: Observational

Clinical Trial Summary

Collection of thermal "images" of women with breast tumors in varying degrees of severity and of healthy women with no breast findings, in order to evaluate and improve Real Imaging's device ("RI4.0"), capabilities which will assist in early detection of breast cancer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1827
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Gender: female

• Age: 18 years and older

• Subjects with a breast abnormality (identified by mammography, ultrasound, MRI and/or a clinical examination) summoned for breast biopsy or subjects summoned for a routine screening examination.

• Subject who have signed an informed consent form.

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 RI4.0.

• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Israel	Hadassah Ein Kerem Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petah Tikva
Israel	Sheba Medical Center	Ramat Gan
Israel	Kaplan Medical Center	Rehovot
Israel	Assuta Ramat Hachayal Hospital	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Real Imaging Ltd.

Country where clinical trial is conducted

Israel,