A Prospective Observational Study to evaluate the Clinical Performance of Thermalytix against Standard Breast Imaging Modalities for detecting breast malignancies in asymptomatic and symptomatic women.
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr Shilpa Rao
- Enrollment
- 6,000
- Locations
- 1
- Primary Endpoint
- Non inferiority by 10% in Sensitivity of Thermalytix when compared to Standard of care (Mammography and USG) for detecting histopath-confirmed-malignant lesions
Overview
Brief Summary
The proposed study is a comprehensive, prospective cohort study aiming to evaluate the efficacy of Thermalytix, a novel AI-based diagnostic tool, in comparison to the standard of care breast imaging modalities for detecting suspicious breast lesions among both asymptomatic and symptomatic women aged 30-80 years. The study will take place at Breast Services Clinic, Department of General Surgery, Seth GSMC and KEM Hospital, Mumbai, and follows a meticulously structured protocol. Prior to imaging procedures, CHVs will engage with the local population as a part of their routine job and will disseminate the details of the BMC breast screening centers in BMC offices. The imaging phase comprises two-view screening mammography and whole breast ultrasound, conducted by trained radiologists at designated centers. The results are graded on the BIRADS scale, with BIRADS 1 and 2 participants not proceeding to the next phase. Participants with BIRADS 3, 4, or 5 results undergo histopathology at KEM Hospital following clinical examination. The study also encompasses the assessment of Thermalytix’s feasibility for population screening, gauging patient experiences in comparison to standard imaging modalities, and collecting demographic data to better understand the affected population. This study design, with its comprehensive approach to breast health screening, follows established medical practices for breast cancer diagnosis and offers a holistic evaluation of novel diagnostic technology’s potential impact in a real-world setting.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 30.00 Year(s) to 80.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Women aged between 30 to 80 years who are either asymptomatic or symptomatic (with breast related symptoms)
- •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
- •Willing and able to comply with scheduled visits, treatment plan, and follow up with research staff.
Exclusion Criteria
- •Participants who fulfil any of the following criteria will be excluded from the study:
- •Women who are pregnant or lactating
- •Women who are in their menstrual cycle at the time of any of the imaging scans
- •Women with prior history of breast cancer, breast surgeries including implants; lumpectomy or surgery <1 year, h/o mastectomy with reconstruction
- •Women who are currently undergoing 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/MRI if indicated 8.
Outcomes
Primary Outcomes
Non inferiority by 10% in Sensitivity of Thermalytix when compared to Standard of care (Mammography and USG) for detecting histopath-confirmed-malignant lesions
Time Frame: 12 months
Secondary Outcomes
- To assess the community prevalence of breast cancer amongst urban females in Mumbai region.(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.(12 months)
- To assess the cost effectiveness & cost effecinecy using a model & feasibility of conducting Thermalytix screening for population(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.(12 months)
Investigators
Prof Dr Shilpa Rao
KEM Hospital