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Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women

PURPOSE: To evaluate the sensitivity and specificity of Thermalytix, an artificial intelligence–based computer-aided diagnostics (CADx) engine, to detect breast malignancy by comparing the CADx output with the final diagnosis derived using standard screening modalities. METHODS: This multisite obser...

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Autores principales: Kakileti, Siva Teja, Madhu, Himanshu J., Krishnan, Lakshmi, Manjunath, Geetha, Sampangi, Sudhakar, Ramprakash, H.V.
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Clinical Oncology 2020
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605380/
https://www.ncbi.nlm.nih.gov/pubmed/33001739
http://dx.doi.org/10.1200/GO.20.00168
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author Kakileti, Siva Teja
Madhu, Himanshu J.
Krishnan, Lakshmi
Manjunath, Geetha
Sampangi, Sudhakar
Ramprakash, H.V.
author_facet Kakileti, Siva Teja
Madhu, Himanshu J.
Krishnan, Lakshmi
Manjunath, Geetha
Sampangi, Sudhakar
Ramprakash, H.V.
author_sort Kakileti, Siva Teja
collection PubMed
description PURPOSE: To evaluate the sensitivity and specificity of Thermalytix, an artificial intelligence–based computer-aided diagnostics (CADx) engine, to detect breast malignancy by comparing the CADx output with the final diagnosis derived using standard screening modalities. METHODS: This multisite observational study included 470 symptomatic and asymptomatic women who presented for a breast health checkup in two centers. Among them, 238 women had symptoms such as breast lump, nipple discharge, or breast pain, and the rest were asymptomatic. All participants underwent a Thermalytix test and one or more standard-of-care tests for breast cancer screening, as recommended by the radiologists. Results from Thermalytix and standard modalities were obtained independently in a blinded fashion for comparison. The ground truth used for analysis (normal or malignant) was the final impression of an expert clinician based on the symptoms and the available reports of standard modalities (mammography, ultrasonography, elastography, biopsy, fine-needle aspiration cytology, and so on). RESULTS: For the 470 women, Thermalytix resulted in a sensitivity of 91.02% (symptomatic, 89.85%; asymptomatic, 100%) and specificity of 82.39% (symptomatic, 69.04%; asymptomatic, 92.41%) in detection of breast malignancy. Thermalytix showed an overall area under the curve (AUC) of 0.90, with an AUC of 0.82 for symptomatic and 0.98 for asymptomatic women. CONCLUSION: High sensitivity and high AUC of Thermalytix in women of all age groups demonstrates the efficacy of the tool for breast cancer screening. Thermalytix, with its automated scoring and image annotations of potential malignancies and vascularity, can assist the clinician in better decision making and improve quality of care in an affordable and radiation-free manner. Thus, we believe Thermalytix is poised to be a promising modality for breast cancer screening.
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spelling pubmed-76053802020-11-09 Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women Kakileti, Siva Teja Madhu, Himanshu J. Krishnan, Lakshmi Manjunath, Geetha Sampangi, Sudhakar Ramprakash, H.V. JCO Glob Oncol ORIGINAL REPORTS PURPOSE: To evaluate the sensitivity and specificity of Thermalytix, an artificial intelligence–based computer-aided diagnostics (CADx) engine, to detect breast malignancy by comparing the CADx output with the final diagnosis derived using standard screening modalities. METHODS: This multisite observational study included 470 symptomatic and asymptomatic women who presented for a breast health checkup in two centers. Among them, 238 women had symptoms such as breast lump, nipple discharge, or breast pain, and the rest were asymptomatic. All participants underwent a Thermalytix test and one or more standard-of-care tests for breast cancer screening, as recommended by the radiologists. Results from Thermalytix and standard modalities were obtained independently in a blinded fashion for comparison. The ground truth used for analysis (normal or malignant) was the final impression of an expert clinician based on the symptoms and the available reports of standard modalities (mammography, ultrasonography, elastography, biopsy, fine-needle aspiration cytology, and so on). RESULTS: For the 470 women, Thermalytix resulted in a sensitivity of 91.02% (symptomatic, 89.85%; asymptomatic, 100%) and specificity of 82.39% (symptomatic, 69.04%; asymptomatic, 92.41%) in detection of breast malignancy. Thermalytix showed an overall area under the curve (AUC) of 0.90, with an AUC of 0.82 for symptomatic and 0.98 for asymptomatic women. CONCLUSION: High sensitivity and high AUC of Thermalytix in women of all age groups demonstrates the efficacy of the tool for breast cancer screening. Thermalytix, with its automated scoring and image annotations of potential malignancies and vascularity, can assist the clinician in better decision making and improve quality of care in an affordable and radiation-free manner. Thus, we believe Thermalytix is poised to be a promising modality for breast cancer screening. American Society of Clinical Oncology 2020-10-01 /pmc/articles/PMC7605380/ /pubmed/33001739 http://dx.doi.org/10.1200/GO.20.00168 Text en © 2020 by American Society of Clinical Oncology https://creativecommons.org/licenses/by-nc-nd/4.0/ Creative Commons Attribution Non-Commercial No Derivatives 4.0 License: https://creativecommons.org/licenses/by-nc-nd/4.0/
spellingShingle ORIGINAL REPORTS
Kakileti, Siva Teja
Madhu, Himanshu J.
Krishnan, Lakshmi
Manjunath, Geetha
Sampangi, Sudhakar
Ramprakash, H.V.
Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title_full Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title_fullStr Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title_full_unstemmed Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title_short Observational Study to Evaluate the Clinical Efficacy of Thermalytix for Detecting Breast Cancer in Symptomatic and Asymptomatic Women
title_sort observational study to evaluate the clinical efficacy of thermalytix for detecting breast cancer in symptomatic and asymptomatic women
topic ORIGINAL REPORTS
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7605380/
https://www.ncbi.nlm.nih.gov/pubmed/33001739
http://dx.doi.org/10.1200/GO.20.00168
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