{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T06:09:13Z","timestamp":1784268553106,"version":"3.55.0"},"reference-count":48,"publisher":"Frontiers Media SA","license":[{"start":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T00:00:00Z","timestamp":1784246400000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["frontiersin.org"],"crossmark-restriction":true},"short-container-title":["Front. Oncol."],"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Breast cancer screening through mammography (MAM) remains the gold standard for early detection. However, MAM implementation faces several challenges, including psychological barriers, resource constraints, and reduced sensitivity in certain populations. Novel screening tools, complementary to mammography, may improve breast cancer detection rates and patient adherence to screening. This study evaluated whether negative results from Celbrea, a novel thermal-based device, were in agreement with negative MAM findings.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>We conducted a single-center retrospective cohort study at an imaging center in Memphis, Tennessee. Eligible participants were healthy women aged 25\u201380 years with bra cup size D or smaller, normal breast skin, and no prior breast cancer diagnosis undergoing routine annual screening MAM. Participants were screened with Celbrea, an FDA-cleared thermal device for breast disease detection. MAM results were classified as negative (BI-RADS 1 or 2) or positive. Celbrea results were classified as either: non-significant (temperature differential \u22642\u00b0F) or significant. We calculated specificity and negative predictive value (NPV) using confusion matrices.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>Of 77 enrolled women, 68 had conclusive results for Celbrea. After excluding 5 women with BI-RADS 0 MAM, 63 were included in the final diagnostic performance analysis. Among these, 56 had negative results on both tests, 1 had a positive MAM (BI-RADS 3) with a non-significant Celbrea result, and 6 had negative MAM with significant Celbrea findings. Overall specificity was 90.3% (95% CI: 80.1-96.4) and NPV was 98.3% (95% CI: 90.6-100.0). Among women with almost entirely fatty or scattered fibroglandular tissue (n=35), specificity was 85.3% (95% CI: 68.9\u201395.1) and NPV was 96.7% (95% CI: 82.8\u201399.9). Among women with heterogeneously or extremely dense breasts (n=28), specificity was 96.4% (95% CI: 81.7\u201399.9) and NPV was 100.0% (95% CI: 87.2\u2013100.0).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Celbrea showed concordance of negative results with MAM. These findings demonstrate good discriminatory capacity and suggest potential clinical utility as an adjunctive or triage tool.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.3389\/fonc.2026.1810073","type":"journal-article","created":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T05:45:55Z","timestamp":1784267155000},"update-policy":"https:\/\/doi.org\/10.3389\/crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["Specificity of Celbrea, a novel noninvasive thermal screening device, in women with recent negative screening mammograms"],"prefix":"10.3389","volume":"16","author":[{"given":"Nickolas","family":"Stabellini","sequence":"first","affiliation":[{"name":"Case Western Reserve University","place":["Cleveland, OH, United States"]},{"name":"Department of Hematology-Oncology, University Hospitals Seidman Cancer Center","place":["Cleveland, OH, United States"]},{"name":"Immunomonitoring Laboratory, Center for Immunotherapy & Precision Immuno-Oncology, Cleveland Clinic","place":["Cleveland, OH, United States"]},{"name":"Division of Cardiology, Department of Medicine, Medical College of Georgia at Augusta University","place":["Augusta, GA, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashley","family":"Hendrix","sequence":"additional","affiliation":[{"name":"Regional One Health","place":["Memphis, TN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lisa","family":"McKnight","sequence":"additional","affiliation":[{"name":"Regional One Health","place":["Memphis, TN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Linnea","family":"Cripe","sequence":"additional","affiliation":[{"name":"Regional One Health","place":["Memphis, TN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alejandra","family":"Alvarez","sequence":"additional","affiliation":[{"name":"Regional One Health","place":["Memphis, TN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jorge","family":"Salazar","sequence":"additional","affiliation":[{"name":"Welwaze Medical Inc","place":["Miami, FL, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Joseph H.","family":"Dayan","sequence":"additional","affiliation":[{"name":"The Institute for Advanced Reconstruction","place":["Red Bank, NJ, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Fleming","sequence":"additional","affiliation":[{"name":"Regional One Health","place":["Memphis, TN, United States"]},{"name":"Department of Surgery, Division of Surgical Oncology, The University of Tennessee Health Science Center","place":["Memphis, TN, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alberto J.","family":"Montero","sequence":"additional","affiliation":[{"name":"Case Western Reserve University","place":["Cleveland, OH, United States"]},{"name":"Department of Hematology-Oncology, University Hospitals Seidman Cancer Center","place":["Cleveland, OH, United States"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1965","published-online":{"date-parts":[[2026,7,17]]},"reference":[{"key":"B1","doi-asserted-by":"publisher","DOI":"10.3322\/caac.21834","article-title":"Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries","volume":"74","author":"Bray","year":"2024","journal-title":"CA Cancer J Clin"},{"key":"B2","unstructured":"WHO position paper on mammography screening"},{"key":"B3","unstructured":"Cancer of the Breast (Female) - Cancer Stat Facts"},{"key":"B4","doi-asserted-by":"publisher","first-page":"1998","DOI":"10.1056\/NEJMoa1206809","article-title":"Effect of three decades of screening mammography on breast-cancer incidence","volume":"367","author":"Bleyer","year":"2012","journal-title":"N Engl J Med"},{"key":"B5","doi-asserted-by":"publisher","DOI":"10.1002\/cncr.32887","article-title":"Breast cancer early detection: a phased approach to implementation","volume":"126","author":"Ginsburg","year":"2020","journal-title":"Cancer"},{"key":"B6","doi-asserted-by":"publisher","first-page":"85","DOI":"10.1016\/j.breast.2022.04.003","article-title":"Global guidelines for breast cancer screening: a systematic review","volume":"64","author":"Ren","year":"2022","journal-title":"Breast"},{"key":"B7","doi-asserted-by":"publisher","DOI":"10.1016\/j.radi.2023.11.016","article-title":"Strategies enhancing the patient experience in mammography: a scoping review","volume":"30","author":"Ding","year":"2024","journal-title":"Radiography"},{"key":"B8","doi-asserted-by":"publisher","DOI":"10.1016\/j.radi.2014.06.010","article-title":"Women\u2019s experiences of mammography: a thematic evaluation of the literature","volume":"21","author":"Clark","year":"2015","journal-title":"Radiography"},{"key":"B9","doi-asserted-by":"publisher","DOI":"10.7812\/tpp\/04-066","article-title":"Mammography screening: addressing myths and other reasons for noncompliance","volume":"9","author":"Mims","year":"2005","journal-title":"Perm J"},{"key":"B10","first-page":"89","article-title":"Rethinking breast cancer screening strategies in resource-limited settings","volume":"10","author":"Galukande","year":"2010","journal-title":"Afr Health Sci"},{"key":"B11","unstructured":"Product - Celbrea\u00ae\n          \n          2021"},{"key":"B12","unstructured":"Clinical Data - Celbrea\u00ae\n          \n          2025"},{"key":"B13","doi-asserted-by":"publisher","DOI":"10.1001\/jama.1982.03320470012007","article-title":"Home device for breast cancer detection","volume":"247","author":"Henahan","year":"1982","journal-title":"JAMA"},{"key":"B14","doi-asserted-by":"crossref","DOI":"10.1007\/978-1-4684-7697-2_90","article-title":"Breast cancer screening indicator (BCSI): a home-use device for the detection of breast pathology","volume-title":"Recent Advances in Medical Thermology","author":"Karpman","year":"1984"},{"key":"B15","doi-asserted-by":"publisher","DOI":"10.1016\/j.tsep.2021.101142","article-title":"Early detection of the breast cancer using infrared technology \u2013 a comprehensive review","volume":"27","author":"Mashekova","year":"2022","journal-title":"Therm Sci Eng Prog"},{"key":"B16","doi-asserted-by":"publisher","DOI":"10.7759\/cureus.31251","article-title":"Thermography as a breast cancer screening technique: a review article","volume":"14","author":"Rakhunde","year":"2022","journal-title":"Cureus"},{"key":"B17","unstructured":"Regional One Health - Specializing in Tomorrows\n          \n          2025"},{"key":"B18","unstructured":"Regional One Health | Tennessee | AHA\n          \n          2024"},{"key":"B19","unstructured":"Establishment Registration & Device Listing"},{"key":"B20","article-title":"Mammography BI RADS grading","volume-title":"StatPearls","author":"Barazi","year":"2025"},{"key":"B21","doi-asserted-by":"publisher","DOI":"10.3389\/fpubh.2017.00307","article-title":"Sensitivity, specificity, and predictive values: foundations, pliabilities, and pitfalls in research and practice","volume":"5","author":"Trevethan","year":"2017","journal-title":"Front Public Health"},{"key":"B22","unstructured":"Generalised Clopper\u2013Pearson confidence intervals for the binomial proportion: Journal of Statistical Computation and Simulation: Vol 76 , No 6 - Get Access"},{"key":"B23","unstructured":"Posit"},{"key":"B24","doi-asserted-by":"publisher","DOI":"10.1158\/1557-3265.SABCS24-P2-09-12","article-title":"Abstract P2-09-12: A public health initiative to enhance screening mammography (MMG) in Northeast Argentina utilizing a novel thermal screening device & breast cancer risk assessment","volume":"31","author":"Maidana","year":"2025","journal-title":"Clin Cancer Res"},{"key":"B25","doi-asserted-by":"publisher","DOI":"10.1093\/jbi\/wbaf014","article-title":"Disparities in breast cancer screening and diagnosis among Black women: a path toward equity","volume":"7","author":"Edmonds","year":"2025","journal-title":"JBI"},{"key":"B26","doi-asserted-by":"publisher","DOI":"10.6004\/jnccn.2023.7023","article-title":"Social determinants of health and racial disparities in cardiac events in breast cancer","volume":"21","author":"Stabellini","year":"2023","journal-title":"J Natl Compr Canc Netw."},{"key":"B27","doi-asserted-by":"publisher","DOI":"10.1038\/s41598-023-27578-4","article-title":"Racial disparities in breast cancer treatment patterns and treatment-related adverse events","volume":"13","author":"Stabellini","year":"2023","journal-title":"Sci Rep."},{"key":"B28","doi-asserted-by":"publisher","DOI":"10.1111\/j.1525-1497.2004.30354.x","article-title":"Obesity and breast cancer screening","volume":"19","author":"Wee","year":"2004","journal-title":"J Gen Intern Med."},{"key":"B29","doi-asserted-by":"publisher","DOI":"10.1001\/archinte.164.10.1140","article-title":"The association between obesity and screening mammography accuracy","volume":"164","author":"Elmore","year":"2004","journal-title":"Arch Intern Med"},{"key":"B30","doi-asserted-by":"publisher","DOI":"10.1056\/NEJM199512283332608","article-title":"Clinical applications of research on angiogenesis","volume":"333","author":"Folkman","year":"1995","journal-title":"N Engl J Med"},{"key":"B31","doi-asserted-by":"publisher","first-page":"383","DOI":"10.1111\/j.1749-6632.1980.tb50764.x","article-title":"Thermopathology of breast cancer: measurement and analysis of in vivo temperature and blood flow","volume":"335","author":"Gautherie","year":"1980","journal-title":"Ann N Y Acad Sci"},{"key":"B32","doi-asserted-by":"publisher","DOI":"10.1007\/BF00666033","article-title":"The influence of angiogenesis research on management of patients with breast cancer","volume":"36","author":"Folkman","year":"1995","journal-title":"Breast Cancer Res Treat"},{"key":"B33","article-title":"Implications of surface temperatures in the diagnosis of breast cancer","volume":"75","author":"Lawson","year":"1956","journal-title":"Can Med Assoc J"},{"key":"B34","doi-asserted-by":"publisher","DOI":"10.1084\/jem.133.2.275","article-title":"Isolation of a tumor factor responsible for angiogenesis","volume":"133","author":"Folkman","year":"1971","journal-title":"J Exp Med"},{"key":"B35","doi-asserted-by":"publisher","DOI":"10.1111\/j.1600-0463.2008.01213.x","article-title":"Tumor-vascular interactions and tumor dormancy","volume":"116","author":"Naumov","year":"2008","journal-title":"APMIS Acta Pathol Microbiol Immunol Scand"},{"key":"B36","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1056\/NEJM199101033240101","article-title":"Tumor angiogenesis and metastasis \u2014 correlation in invasive breast carcinoma","volume":"324","author":"Weidner","year":"1991","journal-title":"N Engl J Med"},{"key":"B37","doi-asserted-by":"publisher","first-page":"30","DOI":"10.1109\/51.844378","article-title":"Functional infrared imaging of the breast","volume":"19","author":"Keyserlingk","year":"2000","journal-title":"IEEE Eng Med Biol Mag Q Mag Eng Med Biol Soc"},{"key":"B38","doi-asserted-by":"publisher","DOI":"10.1155\/2009\/464235","article-title":"Temperature-change-based thermal tomography","volume":"2009","author":"Xu","year":"2009","journal-title":"Int J BioMed Imaging."},{"key":"B39","doi-asserted-by":"publisher","DOI":"10.2214\/ajr.180.1.1800263","article-title":"Efficacy of computerized infrared imaging analysis to evaluate mammographically suspicious lesions","volume":"180","author":"Parisky","year":"2003"},{"key":"B40","unstructured":"10.1177\/1534735408326171\n          A comparative review of thermography as a breast cancer screening technique - Deborah A. Kennedy, Tanya Lee, Dugald Seely, 2009"},{"key":"B41","doi-asserted-by":"publisher","DOI":"10.1109\/51.844381","article-title":"The potential of dynamic area telethermometry in assessing breast cancer","volume":"19","author":"Anbar","year":"2000"},{"key":"B42","doi-asserted-by":"publisher","DOI":"10.1115\/IMECE2012-88244","article-title":"Thermal analysis of cancerous breast model","volume":"2012","author":"Chanmugam","year":"2012"},{"key":"B43","doi-asserted-by":"publisher","first-page":"464235","DOI":"10.1155\/2009\/464235","article-title":"Temperature-change-based thermal tomography","volume":"2009","author":"Xu","year":"2009"},{"key":"B44","doi-asserted-by":"publisher","DOI":"10.1080\/10255849908907987","article-title":"Surface temperature distribution of a breast with and without tumour","volume":"2","author":"Sudharsan","year":"1999"},{"key":"B45","doi-asserted-by":"crossref","unstructured":"e0281153\n          \n            \n              White\n              T\n            \n            \n              Algeri\n              S\n            \n          \n          10.1371\/journal.pone.0281153\n          Estimating the lifetime risk of a false positive screening test result - PMC\n          18\n          2023","DOI":"10.1371\/journal.pone.0281153"},{"key":"B46","doi-asserted-by":"publisher","DOI":"10.7326\/M15-0970","article-title":"Harms of breast cancer screening: systematic review to update the 2009 U.S. preventive services task force recommendation","volume":"164","author":"Nelson","year":"2016"},{"key":"B47","doi-asserted-by":"crossref","unstructured":"Brodersen\n              J\n            \n            \n              Siersma\n              VD\n            \n          \n          10.1370\/afm.1466\n          Long-term psychosocial consequences of false-positive screening mammography - PMC\n          11\n          2013","DOI":"10.1370\/afm.1466"},{"key":"B48","doi-asserted-by":"crossref","unstructured":"307\n          \n            \n              Trevethan\n              R\n            \n          \n          10.3389\/fpubh.2017.00307\n          Frontiers | Sensitivity, specificity, and predictive values: foundations, pliabilities, and pitfalls in research and practice\n          5\n          2017","DOI":"10.3389\/fpubh.2017.00307"}],"container-title":["Frontiers in Oncology"],"original-title":[],"link":[{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fonc.2026.1810073\/full","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,7,17]],"date-time":"2026-07-17T05:46:07Z","timestamp":1784267167000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.frontiersin.org\/articles\/10.3389\/fonc.2026.1810073\/full"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,7,17]]},"references-count":48,"alternative-id":["10.3389\/fonc.2026.1810073"],"URL":"https:\/\/doi.org\/10.3389\/fonc.2026.1810073","relation":{},"ISSN":["2234-943X"],"issn-type":[{"value":"2234-943X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,7,17]]},"article-number":"1810073"}}