NCT03990012

Infrared Imaging for Breast Cancer Modeling

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to obtain infrared (IR) images and video and three-dimensional (3-D) scans of patients referred for biopsy based on the results of their diagnostic breast exam(s). This research study is investigating infrared imaging (also referred to as infrared thermography, or digital infrared thermal imaging (DITI)) of breast cancer. The infrared images collected in this study will be used to construct a computational biothermal engineering model of the cancerous breast. Patients will undergo standard breast cancer screening procedures as part of routine care at Parkland Comprehensive Breast Center. For any patients who are referred for biopsy based on the results of their breast cancer screening procedures, this research study will take infrared images of the patient. Patients will undergo infrared imaging prior to biopsy but will not delay biopsy or treatment; infrared images \& video may be recorded at biopsy visit. The biopsy will confirm/diagnose whether the patient has a benign or malignant condition.

Detailed description

The purpose of this research study is to obtain IR images, IR video, and 3-D scans of female patients' breasts (i.e., thermograms) who have been referred for biopsy based on the results of their diagnostic breast exams. These patients may be later diagnosed with a malignant or benign breast condition. The infrared images and video collected will be used to construct and validate a computational biothermal engineering model of breast cancer. This research study does not involve any investigational drugs or treatments. This research study does not involve any FDA-approved drugs or devices. In this research study, the equipment used (IR camera, 3-D scanner) will no be tested nor be used to diagnose or treat. Further, medical decisions will not be based on the use of these devices. Infrared imaging (or digital thermal infrared imaging, DITI) is a non-invasive, non-contact, and harmless imaging procedure that measures the natural infrared radiation (body heat) emitted by the human body at normal 37°C body temperature. This procedure does not expose the patient to any radiation and is therefore entirely safe for the patient. IR images and video will be obtained by IR equipment provided by University of Texas (UT) at Dallas researchers. IR equipment consists of an IR camera and ancillary equipment (e.g., tripod, computer, and vendor-provided IR image-processing software). The IR camera that will be used will be a commercial off-the-shelf product. Additionally, a 3-D scanner will be used to obtain a 3-D surface contour map of the patient's breasts. This 3-D scanner is also non-invasive, non-contact, and does not expose the patient any radiation, similar to the IR camera. The 3-D scanner outputs a file format that is compatible with 3-D computer-aided design (CAD) software for engineering analysis.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	IR Imaging	Subjects will undergo steady steady state and video IR imaging of the breasts.
PROCEDURE	3D Scanning	Subjects will undergo 3D scanning of the breasts.

Timeline

• Start date: 2019-06-13
• Primary completion: 2021-12-15
• Completion: 2022-06-01
• First posted: 2019-06-18
• Last updated: 2022-08-02

Locations

1 site across 1 country: United States