None listed
Conditions
Interventions
Intervention1: Thermalytix: Thermalytix is a Software medical device that analyzes thermal distribution on breast to generate quantitative analysis report.
Control Intervention1: Mammography and Breas
Sponsors
Dr Shilpa Rao
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women aged between 30 to 80 years who are either asymptomatic or symptomatic (with breast related symptoms) 2. Capable of understanding the investigational nature of the study and all pertinent aspects of study 3. Capable of signing and providing written consent in accordance with institutional and federal guidelines 4. Willing and able to comply with scheduled visits, treatment plan, and follow up with research staff
Exclusion criteria
Exclusion criteria: Participants who fulfil any of the following criteria will be excluded from the study: 1. Women who are pregnant or lactating 2. Women who are in their menstrual cycle at the time of any of the imaging scans 3. Women with prior history of breast cancer, breast surgeries including implants; lumpectomy or surgery 4. Women who are currently undergoing breast cancer treatment including chemotherapy or radiotherapy in the last 6 months 5. Women who are undergoing hormonal therapy 6. Unable to complete study-related procedures 7. Patients not willing to undergo USG/Biopsy/MRI if indicated 8. Incapable of or not willing to give consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Non inferiority by 10% in Sensitivity of Thermalytix when compared to Standard of care (Mammography and USG) for detecting histopath-confirmed-malignant lesionsTimepoint: 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the community prevalence of breast cancer amongst urban females in Mumbai region.Timepoint: 12 months;To compare the patient experience of Thermalytix in comparison with Mammography, Breast Ultrasound, & their combination in detecting breast abnormalities based on PSQ-18 scale.Timepoint: 12 months;To assess the cost effectiveness & cost effecinecy using a model & feasibility of conducting Thermalytix screening for populationTimepoint: 12 months;To assess the Sensitivity & Specificity of Thermalytix in comparison with Mammography, Breast Ultrasound, & their combination in detecting breast abnormalities, with a specific focus on their performance in identifying true-positive cases when compared to histopathological findings.Timepoint: 12 months | — |
Countries
India
Contacts
Public ContactProf Dr Shilpa Rao
KEM Hospital
Outcome results
None listed