Background Serum tumour markers, cancer antigen 15–3 (CA 15–3) and carcinoembryonic antigen (CEA) are not routinely recommended for detecting breast cancer recurrence and monitoring treatment. In this study, we aim to evaluate the diagnostic accuracy of absolute CA 15–3 and CEA levels and report on the clinical utility of tumour marker velocity in breast cancer surveillance. Methods 67 consecutive patients over a 15-year period (1998–2012) with available serial serum CA 15–3 and CEA measurements at recurrence were matched to a control group of patients. Tumour marker velocity was derived from the average change in consecutive tumour marker values over time, expressed in unit/year. Logistic regression analysis was performed to investigate the association between tumour characteristics, tumour marker velocity and disease recurrence. Results Using the Youden index values, the optimal cut-off values for absolute CA 15–3 and CEA corresponded to the normal assay reference range while tumour marker velocity values were derived to be 2.5U/mL/year and 1.2ng/mL/year respectively. CA 15–3 velocity > 2.5U/mL/year had the highest AUROC value of 0.85 than CEA velocity alone. When either tumour marker velocity exceeded threshold values, the sensitivity, specificity, negative predictive value and positive predictive value were 94.0%, 73.1%, 92.5%, and 77.8% respectively. In the multivariate logistic regression analysis, having both CA 15–3 and CEA velocity exceeding the cut-off values was shown to be a significant predictor for disease recurrence (p = 0.01). Conclusion These findings highlighted the clinical utility of serial tumour markers measurements and its velocity in breast cancer surveillance.
IntroductionMachine learning in computer-assisted diagnostics improves sensitivity of image analysis and reduces time and effort for interpretation. Compared to standard mammograms, a thermal scan is easily scalable and is a safer screening tool. We evaluate the performance of Thermalytix (an automated thermographic screening algorithm) compared with other standard breast cancer screening modalities.MethodsA prospective multicentre study was conducted to assess the non-inferiority of sensitivity of Thermalytix (test device) to that of standard modalities in detecting malignancy in subjects who show possible symptoms of suspected breast cancer. Standard screening modalities and Thermalytix were obtained and interpreted independently in a blinded fashion. A receiver operating characteristic (ROC) curve was constructed to identify the best cut-off point, non-inferiority margin of ≥10% to demonstrate the non-inferiority.ResultsWe recruited 258 symptomatic women who first underwent a thermal scan, followed by mammogram and/or ultrasound. At Youden’s Index of ROC curve, the test device had a sensitivity of 82.5% (95% CI 73.2 to 91.9) and specificity of 80.5% (95% CI 75.0 to 86.1) as compared with diagnostic mammogram, which had sensitivity of 92% (95% CI 80.7 to 97.8) and specificity of 45.9% (95% CI 34.3 to 57.9) when BI-RADS 3 (Breast Imaging-Reporting and Data System) was considered as test-positive. The overall area under the curve (AUC) was 0.845. For women aged <45 years, the test device had a sensitivity and specificity of 87.0% (95% CI 66.4 to 97.2) and 80.6% (95% CI 72.9 to 86.9), respectively. For women aged ≥45 years, the sensitivity and specificity were 80.5% (95% CI 65.1 to 91.2) and 86.5% (95% CI 78.0 to 92.6, respectively).ConclusionWe evaluated Thermalytix, a new AI-based modality for detecting breast cancer. The high AUC in both women under 45 years and above 45 years shows the potential of Thermalytix to be a supplemental diagnostic modality for all ages. Further evaluation on larger sample size is needed.Trial registration numberCTRI/2017/10/0 10 115;
Introduction: Breast cancer is the largest cause of cancer deaths in women today. NIRAMAI has developed a novel solution for detecting early stage breast cancer in women of all age groups. It is low cost, non-contact and portable solution. This radiation-free solution also works on dense breasts and hence is applicable beyond developing countries. The core of the solution is a Computer Aided Diagnostics engine called Thermalytix, which uses Artificial Intelligence algorithms on high resolution thermal images. In this paper, we present a comparative analysis of Thermalytix solution with Mammography, the standard screening modality, in a retrospective trial that was conducted across 3 reputed cancer hospitals in India. Aim: To compare the sensitivity, specificity, NPV and PPV of Thermalytix with Mammography. Methods: A multisite comparative study was performed on 194 patients across 3 reputed cancer hospitals in India with informed consent from subjects and ethics committee approval of respective hospitals. Every person who was going for a mammography test was made to undergo the non-invasive Thermalytix test prior to mammography examination. As per standard of care in India, all women who had a suspicious lesion in Mammo was sent to Ultrasound and then biopsy. 93 of the 194 subjects enrolled were found to be malignant by this standard procedure (9 of them did not have a biopsy report). Niramai Thermaytix test gave the automated reports detecting patients with suspected malignancy and those results were compared with ground truth derived from mammography, sono-mammography and biopsy. In a similar manner, standalone mammography observation was compared with the above ground truth to compare the two modalities as individual modalities. Results: Out of the 194 subjects, 93 positive cases and Niramai accurately detected 91 cases and called out one as boundary case. Sensitivity of Thermalytix was 98% and NPV was 97%, while sensitivity of Mammography was 94% with an NPV of 94%. NIRAMAI Thermalytix detected 4 more malignant patients compared to Mammography. On the other hand, mammography scored over Thermalytix in PPV and Specificity by 10%. These results are tabulated at Comparing NIRAMAI Thermalytix with Mammography NIRAMAIMammographySensitivity98%94%Specificity76%89%PPV79%89%NPV97%94%Accuracy87%91%Number of subjects = 194 high risk patients Among the 194 patients, 39 women were found to have dense breasts and 19 with heterogenous dense breasts – on whom ultrasound and elastography was performed by the Radiologist to correlate with mammography results and make the final observations. Niramai test alone was effective in these patients. The results show that Thermalytix is an emerging, radiation-free diagnostic modality that has comparable accuracy to Mammography. We conclude that NIRAMAI Thermalytix can be complementary modality to mammography as it works well on women of all age groups, including women with dense breasts. Its higher sensitivity and NPV adds to its potential to be the first screening test for early detection of breast cancer. Citation Format: Manjunath G, Sudhakar S, Kakileti S, Madhu H, Singh A. Artificial Intelligence over thermal images for radiation-free breast cancer screening [abstract]. In: Proceedings of the 2018 San Antonio Breast Cancer Symposium; 2018 Dec 4-8; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2019;79(4 Suppl):Abstract nr P6-02-12.
Background: In October 2019, surgeons from Changi General Hospital (CGH) Breast Centre delivered a series of health talk for its employees to assess the knowledge and perception of breast cancer screening and improve related knowledge of the institution’s healthcare workers. This is to enable CGH, a healthcare provider to not only care for our patients, but also look after its staff. Methods: 141 hospital staff attended a 40-minute talk followed by an open question and answer forum. Pre and post talk surveys were conducted to gauge knowledge, attitudes, beliefs and misconceptions towards breast cancer screening and treatment. Question domains were divided into 1) breast cancer knowledge, 2) breast cancer screening guidelines,3) attitudes and perception of breast cancer screening and treatment. Univariate and multivariate logistic regression analysis was used to examine the relationship between demographics and performance in question domains.Results: The overall response rate was 131 out of a total of 141 attendees (92.9%). The median age was 44 (range, 22 to 67), with nursing staff making up 40% of the cohort. Analysis showed statistically significant improvement in median score across all 3 domains. (p<0.05) after the forum. We found that respondents who were women ≥40 years (eligible age for screening), had higher income, lived in larger housing types, had attended previous talks, had served >10 years in healthcare and had personal encounter with breast cancer patients performed better. Surprisingly, being a nurse or having a university degree did not translate to better score. 99% of respondents find the forum beneficial and will recommend to others. Several knowledge gap about breast cancer screening and misconceptions were identified. Future campaign should focus on raising awareness of the national screening program BreastScreen Singapore. We advocate to reinforce its recommendations, promote on the affordability and ready accessibility. As healthcare personnel are ambassadors of the healthcare system, their knowledge would aid in providing accurate information to patients and public, enabling them to make wise healthcare choices.Conclusions: A simple Breast Cancer Awareness Month campaign targeted at healthcare workers was found to be effective at educating hospital staff on breast cancer, screening practices and improving perception of screening and treatment practices. This may empower them to not only care for themselves but help serve patients better.
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