Computer enabled autofluorescence device for the diagnosis of breast lumps and determining completeness of surgical removal of breast tumours
Phase 2
- Conditions
- Health Condition 1: D249- Benign neoplasm of unspecified breastHealth Condition 2: C508- Malignant neoplasm of overlappingsites of breast
- Registration Number
- CTRI/2024/02/062338
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Benign or malignant lump in the breast
2. Patients planned for surgical excision of lump (Lumpectomy and Wide Local Excision) or removal of the breast (Mastectomy)
Exclusion Criteria
1. Patients below 18 years age
2. Male patients
3. Patients not willing or not planned for surgical excision of breast lump
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ability to differentiate autofluorescence spectral signatures of normal, benign and malignant tissues in the breast by using the novel investigational device in ex-vivo conditionTimepoint: 1 hour
- Secondary Outcome Measures
Name Time Method Ability of a machine learning model to differentiate normal, benign and malignant <br/ ><br> spectral signatures obtained from the breast tissueTimepoint: 1 year