Health Condition 1: D249- Benign neoplasm of unspecified breast Health Condition 2: C508- Malignant neoplasm of overlappingsites of breast
Conditions
Interventions
Intervention1: Novel class C device to detect autofluorescence spectra from breast tissue: Breast lump or whole breast is excised during the Standard of Care surgery. A novel Class C device is passed
Sponsors
Indian Council of Medical Research
Eligibility
Inclusion criteria
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
Exclusion criteria: 1. Patients below 18 years age 2. Male patients 3. Patients not willing or not planned for surgical excision of breast lump
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Ability of a machine learning model to differentiate normal, benign and malignant spectral signatures obtained from the breast tissueTimepoint: 1 year | — |
Countries
India
Contacts
Public ContactDr Badareesh L
Kasturba Medical College Manipal
Outcome results
None listed