A Safe and Non-invasive Breast Cancer Screening Solution

Completed

Conditions: Malignant neoplasm of breast of unspecified site, (2) ICD-10 Condition: R688||Other general symptoms and signs, possible symptoms of suspected breast cancer ,

Registration Number: CTRI/2017/10/010115

Lead Sponsor: NIRAMAI Health Analytix Pvt Ltd

Brief Summary: Breast cancer is one of the crucially prevailing cancers among women. Early detection and diagnosis of breast cancer is very important for patient survival. Currently, mammography is the most common method used for detection of breast cancer. 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 women and is inconclusive on women with high density of breast. 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 tissue is higher around the regions where a tumor is present. A high resolution thermal camera can be used to capture this thermal information. This thermal image representing the temperature variations observed on the breast is called a breast thermogram. 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. Particularly, radiologists who are also certified thermologists are able to interpret these breast thermograms to determine its malignancy or benign condition. However, manual interpretation of these themograms is very cumbersome and error prone. Thermalytix is a new method of interpreting thermal images using CAD anovel Artificial Intelligence and Machine Learning Algorithms and has shown promising results in early experiments.

Our proposed research is to improve breast cancer screening through low cost, mobile, non-invasive and non-contact thermal screening without causing any discomfort to patients and develop accurate interpretation algorithms using machine learning, image processing and computer vision techniques to give automated screening capabilities.

In this study, sensitivity of ThermalytixÂ© (an automated thermographic screening algorithms developed by NIRAMAI) will be compared to the sensitivity of standard screening modalities. The entry criteria for the study will be subjects who show possible symptoms of suspected breast cancer, such as pain, lump and so on.

The primary objectives of the study are to assess a non-inferiority of sensitivity of ThermalytixÂ© methodology over the sensitivity of standard screening procedures by not more than 10% and study comparative diagnostic performance of ThermalytixÂ© with standard screening modalities. The endpoint measurements would be sensitivity, specificity, PPV (Positive Predictive Values) and NPV (Negative Predictive Values) in the detection of breast cancer in women.

Secondary Objectives would be to study the influence of effects of patient characteristics on diagnostic accuracy. Patient characteristics would include, Age, Lesion type, Pathologic diagnosis, Menopausal and hormonal status, Breast density and Family history. Also to study how ThermalytixÂ© can complement the standard modalities in breast cancer screening in future

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

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Female

Target Recruitment: 275

Inclusion Criteria

Female subjects equal to and above 18 years presenting with the following breast abnormalities: (1a) Palpable lump, swelling or mass in breast (1b) Persistent breast pain or tenderness that is unrelated to menstrual cycle (1c) Nipple is inverted or tender, painful, scaly or with discharge (clear or bloody) (1d) Skin on breast is dimpled, red, blotchy, pricking, itchy or has change in the texture (1e) Increase in breast size that is not related to menstrual cycle (1f) Thickening in or around the breast or underarm area (1g) Or any other symptoms leading to suspicion of breast cancer 2.
Subjects who are willing to give written informed consent for study participation 3.
Subjects who are ready to comply with the study related visits and procedures.

Exclusion Criteria

Subjects who are pregnant 2.
Subjects who are lactating 3.
Subjects who have undergone either lumpectomy or mastectomy 4.
Subjects who have undergone Chemotherapy in the last 2 weeks at the time of study enrollment 5.
Any active illness, psychological and/or pathological condition that would interfere with study participation in the opinion of the Investigator.

Study & Design

Study Type: Observational

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. non-inferiority of sensitivity of Thermalytix to not more than 10% of the standard screening modalities	24 weeks
2.Sensitivity	24 weeks
3. Specificity	24 weeks
4.PPV	24 weeks
5.NPV	24 weeks

Secondary Outcome Measures

Name	Time	Method
1. Influence of patient characteristics on diagnostic accuracy of ThermalytixÂ©.	Patient characteristics will include:

Trial Locations

Locations (2): HCG Cancer Hospital
🇮🇳
Bangalore, KARNATAKA, India
Mazumdar Shaw Medical Center
🇮🇳
Bangalore, KARNATAKA, India
HCG Cancer Hospital
🇮🇳Bangalore, KARNATAKA, India
Dr S Sudhakar
Principal investigator
08040206000
dr_sudhakar79@yahoo.com