Health Condition 1: C50- Malignant neoplasm of breast
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: DA of MRI and DA of CEM: DA of MRI and DA of CEM
Control Intervention1: NA: NA
Control Intervention2: HPR as gold standard: HPR as gold standard
Sponsors
Tata Memorial Centre
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria: 1. Patients consenting for participation in the study. 2. Non-metastatic at the time of presentation. 3. cT1-4 and cN0-3 at the time of presentation. 4. Mammogram, USG, CEM and MRI either performed in TMH, or done outside, with adequate quality DICOM images uploaded on PACS. 5. Patients undergoing CEM guided or MRI guided or relook USG guided biopsy if indicated at TMH/ACTREC; but may not undergo breast conservative surgery {These patients will be included in the study as rad- path correlation of these additional findings will be available} 6. Patients undergoing surgical and/ or medical management at TMH/ACTREC. 7. Biopsy specimen if eligible and complete surgical specimen provided to our institutional pathology department.
Exclusion criteria
Exclusion criteria: Pregnant patients. Metastatic disease at the time of presentation. More than 18 years of age.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of proportion of change in surgical plan due to contrast based imaging findings. Events considered as change in surgical plan due to additional findings will be following categories: Category 1. Breast conservative surgery to mastectomy Category 2. Mastectomy to breast conservative surgery Category 3. For cases remaining as breast conservative surgery, extended resection leading to either expected change in cosmesis or requirement of oncoplasty due to contrast based imaging finding will be considered as change in management. Category 4. Decision to start NACT. Timepoint: at 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of disease extent on non-contrast-based imaging (Mammogram, USG), based on CEM and/or MRI (the modality which will determined the surgical outcome) & clinically determined extent of disease with histopathological extent of disease. 2. Diagnostic accuracy of contrast imaging detected additional findings with histopathology correlation as a gold standard. Timepoint: At Baseline | — |
Countries
India
Contacts
Public ContactDr Tejal vijay ogale
Tata Memorial Centre
Outcome results
None listed