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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

575 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-11-30

Study Completion Date

2009-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT00821613

Breast Cancer

COMPLETED

A Data Collection Study for the Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment

NCT02505698

Breast Cancer

WITHDRAWN

Microwave Radiometry for the Diagnosis and Monitoring of Breast Cancer

NCT02514837

Breast Cancer

WITHDRAWN

Evaluation of a Novel Infra-red Breast Imaging System for Risk Assessment in Women at High Risk for Breast Cancer.

NCT02009150

Breast Cancer

UNKNOWN

Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions

NCT01004666

Small Breast Lesions Dense Breast Tissue Discrepancy With Clinical Examination +1 more

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No