Infrared Imaging for Breast Cancer Modeling

NCT03990012 | Completed

• 1 other identifier: STU-2018-0370
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Patients referred for breast biopsy

EXPERIMENTAL

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; Procedure: 3D Scanning

Interventions

IR Imaging PROCEDURE

Subjects will undergo steady steady state and video IR imaging of the breasts.

Patients referred for breast biopsy

3D Scanning PROCEDURE

Subjects will undergo 3D scanning of the breasts.

Patients referred for breast biopsy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

Parkland Memorial Hospital

Dallas, Texas, 75235, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Jody Hayes, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 21, 2019
• First Posted: June 18, 2019
• Study Start: June 13, 2019
• Primary Completion: December 15, 2021
• Study Completion: June 1, 2022
• Last Updated: August 2, 2022

Record last verified: 2022-07

Locations

US (1)