A study to evaluate the effectivity of Portable Ultrasound Device in differentiating benign and malignant disease in patients with palpable breast lump
Not Applicable
- Conditions
- Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
- Registration Number
- CTRI/2023/03/050522
- Lead Sponsor
- International Agency for Research on Cancer (World Health Organization)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
Women positive on CLinical Breast Examination
Exclusion Criteria
Women with debilitating illness
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the agreement between PUD and mammography /ultrasound by a radiologist in differentiating malignant and benign solid breast lesionsTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.
- Secondary Outcome Measures
Name Time Method To collect annotated images of breast ultrasound for future development of artificial algorithm in breast cancer detectionTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.;To develop a diagnostic algorithm that incorporates PUD in the triage of breast lumps detected on CBE to avoid unnecessary imaging and biopsy procedures for benign lumpsTimepoint: Recruitment of women: 18 months, <br/ ><br>Outcome data assessment and analysis: at the end of 18 months.