Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Thermalytix Breast Imaging device: Novel breast cancer detection tool based on artificial intelligence analysis of breast thermal images
Control Intervention1: mammography and ultrasoun
Sponsors
Niramai Health Analytix Pvt Ltd, Bangalore
Eligibility
Inclusion criteria
Inclusion criteria: Asymptomatic or symptomatic women who are capable of understanding the investigational nature of the study and all pertinent aspects of study capable of signing and providing written consent in accordance with institutional and federal guidelines In the situation where participant is unable to read or write, In this situation, the consent form will be read out to the participant in the local language and thumb print obtained willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
Exclusion criteria
Exclusion criteria: Women who are pregnant or lactating Women who have had breast palpation within the past 72 hours Women who have had their menstrual cycle within 7 days Women with prior history of breast cancer, breast surgeries including implants; lumpectomy or surgery Women who are currently or who had breast cancer treatment including chemotherapy or radiotherapy in the last 6 months Women who are undergoing hormonal therapy Unable to complete study-related procedures Patients not willing to undergo USG/Biopsy/PET/MRI if indicated Incapable of or not willing to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sensitivity, specificity, negative & positive predictive values, diagnostic accuracy of Mythri-Thermalytix & CBE when compared to one or more of the following reference tests- breast ultrasound, MRI or histopathology Timepoint: at time of test & at one year | — |
Secondary
| Measure | Time frame |
|---|---|
| The agreement between / correlation of Mythri-Thermalytix, CBE & ultrasound diagnosisTimepoint: at time of test & after one year | — |
Countries
India
Contacts
Public ContactProf Dr Shilpa Rao
Seth GS Medical College and KEM Hospital
Outcome results
None listed