Infrared Imaging for Breast Cancer Modeling

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: IR Imaging; Procedure: 3D Scanning

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75235
      • Parkland Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Females with a suspicious breast mass (BI-RADS 4C or 5).
• Referred for a breast biopsy.
• Capable of providing informed consent.

Exclusion Criteria:

• Currently undergoing treatment for breast cancer.
• Incapable of providing informed consent.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patients referred for breast biopsy; Patients with Breast Imaging-Reporting and Data System (BI-RADS) 4C or 5 diagnosis who have been referred for breast biopsy based on the results of their standard diagnostic breast exam will undergo IR and 3D imaging of the breasts.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spatial location of breast tumors	Researchers will use subjects' radiological imaging data to quantify the location of the tumor inside the breast, including mammography, ultrasound, and/or magnetic resonance imaging (MRI), for patients who are diagnosed with breast cancer. The tumor location will be measured. The tumor location will serve as an input for the computational model. No diagnostic assessments will be made from these data for this research study.	Two years
3-D Surface contour maps of the breast	Researchers will use a 3-D scanning device to reconstruct the 3-D surface geometry of subjects' breasts. The surface geometry of subjects' breasts will be measured. The surface geometry will serve as an input for the computational model. No diagnostic assessments will be made from these data for this research study.	Two years
Computational thermal model of breast cancer	Researchers will use study data to validate a computational biothermal engineering model of the cancerous breast. The computational model will model and simulate the internal thermodynamic and heat transfer processes inside the breast with cancer. The model outputs expected surface temperatures of the breast with cancer. The model will be constructed using commercial engineering software, ANSYS Fluent. No diagnostic assessments will be made from these data for this research study.	Two years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Investigators: Principal Investigator: Jody Hayes, MD, UT Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 13, 2019
• Primary Completion (Actual): December 15, 2021
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: May 21, 2019
• First Submitted That Met QC Criteria: June 14, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 2, 2022
• Last Update Submitted That Met QC Criteria: July 29, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: STU-2018-0370

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No