Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
11 participants
INTERVENTIONAL
2019-06-13
2022-06-01
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
IR Imaging
Subjects will undergo steady steady state and video IR imaging of the breasts.
3D Scanning
Subjects will undergo 3D scanning of the breasts.
Interventions
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IR Imaging
Subjects will undergo steady steady state and video IR imaging of the breasts.
3D Scanning
Subjects will undergo 3D scanning of the breasts.
Eligibility Criteria
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Inclusion Criteria
* Referred for a breast biopsy.
* Capable of providing informed consent.
Exclusion Criteria
* Incapable of providing informed consent.
18 Years
FEMALE
No
Sponsors
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University of Texas Southwestern Medical Center
OTHER
Responsible Party
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Jody Hayes
Assistant Professor
Principal Investigators
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Jody Hayes, MD
Role: PRINCIPAL_INVESTIGATOR
UT Southwestern Medical Center
Locations
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Parkland Memorial Hospital
Dallas, Texas, United States
Countries
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Other Identifiers
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STU-2018-0370
Identifier Type: -
Identifier Source: org_study_id
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