Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Intraoperative margin assessment using Specimen Mammography Alone: after randomisation, the patients intraoperative margin will be assessed and revised only based on mammography report
Sponsors
All India Institute of Medical sciences jodhpur
Eligibility
Inclusion criteria
Inclusion criteria: female patients aged more than 35 years Histologically confirmed invasive breast carcinoma or DCIS Disease suitable for breast conserving surgery Preoperative lesion localization feasible by mammography/ultrasound Written informed consent obtained
Exclusion criteria
Exclusion criteria: Locally advanced or metastatic breast cancer Multifocal/multicentric disease not amenable to single lumpectomy Prior surgery in same breast Patients unwilling/unfit for surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic reliability and margin negativity rate of specimen mammography alone compared to specimen mammography with frozen section, using final histopathology as gold standard. Timepoint: immediately assessed in the OT at the time of Mammography/Mammography + Frozen section and at the time of final histopathology report (approx 2 to 3 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Re-excision rates between both groups Operative time and intraoperative workflow efficiency Correlation between radiological and histopathological margin status Diagnostic performance of AI-assisted specimen mammography interpretation Identification of patient subgroups requiring frozen section Timepoint: During surgery and at final histopathology/postoperative analysis | — |
Countries
India
Contacts
Public ContactDr Prathap R
All India Institute Of Medical Sciences- Jodhpur
Outcome results
None listed