A prospective study to evaluate the effectiveness of Thermalytixâ„¢ (AI-based thermographic screening solution) for preventive screening, diagnosis, and monitoring of breast cancer patients.

Cancer of the breast is the most common cause of cancer-related death in India. Detecting breast cancer at early stages is crucial for providing treatment and reducing disease morbidity and mortality. Mammography is the only known method to reduce breast cancer mortality. However, mammography has certain limitations. It is not recommended to be used on women under the age of 45 years, cannot be used on lactating/pregnant women, is less effective on women with high density of breast, and repeated mammography comes with a risk of radiation-induced breast cancer.  Mammography in correlation with sono-mammography is widely used currently for screening in hospitals.

Infrared imaging of the breast or thermography is an imaging technique which detects suspected malignancy based on thermal changes on the chest. Due to increased blood circulation and metabolic activity of the tumour, the temperature of the tumour tissue is higher than the surrounding areas. This thermal information is captured by a high-resolution thermal camera. A thermal image provides a visual representation of the temperature distribution and can be used for clinical interpretation of abnormal breast conditions as an adjunct modality. Certain trained clinicians who are certified thermologists can interpret these breast thermograms to determine its malignancy or benign condition. However, manual interpretation of these thermograms is very cumbersome and error prone. Thermalytixâ„¢, a novel artificial intelligence and machine learning-based CAD system, is a new method of interpreting thermal images that has shown higher sensitivity and comparable specificity when compared with mammography in early experiments. Thermalytixâ„¢ is a non-contact, non-invasive, radiation-free, affordable and is also applicable to women under 45 years and those with dense breasts.

In this study, the entry criteria for the study will be asymptomatic women, symptomatic women who show possible symptoms of suspected breast cancer, such as pain, lump and so on, and women who come for follow-up after diagnosis/treatment of breast cancer. The primary objectives of the study are to assess a non-inferiority of sensitivity of Thermalytixâ„¢ over the sensitivity of standard screening procedures by not more than 10% and study comparative diagnostic performance of Thermalytixâ„¢ with standard screening modalities in asymptomatic and symptomatic women. The endpoint measurements would be sensitivity, specificity, PPV, and NPV in the detection of breast cancer in women without an earlier history of breast cancer. The secondary objectives include evaluating the performance of Thermalytixâ„¢ in women previously diagnosed with breast cancer, study the influence of effects of patient characteristics on diagnostic accuracy and the evaluation of changes in Thermalytix scores of women who come for follow-up after diagnosis or treatment of breast cancer across various visits. Also, Thermalytixâ„¢ as a complement to the standard modalities in breast cancer will be evaluated. A publication at the end of each year will be targeted.

This protocol for human research study will be conducted according to standards of effective Good Clinical Practice (International Conference on Harmonization [ICH] Guidelines), applicable Indian regulations and applicable Ethical Guidelines for Biomedical Research involving Human Participants issued by the Indian Council of Medical Research. The trial protocol and study participant documentation were reviewed and approved by the Institutional Ethical Review Boards of the participating trial site.