A prospective non-interventional multicenter cohort study to evaluate different imaging-guided methods for localization of malignant breast lesions
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- 1. Intended target lesion and/or marker removal, independent of margin status on final
Overview
Brief Summary
This is a multivcentre international observational study. The aim of the proposed study is to comparatively evaluate different imaging-guided localization methods used for surgical removal of non-palpable malignant breast lesions with regard to oncological safety and patient-reported outcomes.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 70.00 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •Signed consent
- •Malignant breast lesion requiring breast-conserving surgery and imaging-guided localization (either DCIS or invasive breast cancer; multiple or bilateral lesions and the use of neoadjuvant chemotherapy are allowed)
- •Planned surgical removal of the lesion using one or more of the following imaging guided localization techniques (Wire, intraoperative USG, Dye, seed).
Exclusion Criteria
- •Patients not suitable for surgical treatment
- •Patients requiring mastectomy as first surgery
- •Surgical removal without imaging-guided localization.
Outcomes
Primary Outcomes
1. Intended target lesion and/or marker removal, independent of margin status on final
Time Frame: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
histopathology
Time Frame: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
2. Negative resection margin rates (defined as lesion removal with no invasive or
Time Frame: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
non-invasive carcinoma on ink) at first surgery
Time Frame: 1. At Baseline before image-guided localisation | 2. During Surgery | 3. At 2 weeks after Surgery | 4. At 4 weeks after Surgery
Secondary Outcomes
- - Rates of second surgery, mastectomy, resection ratio, marker dislocation rates(- Volume and weight of resected tissue)
Investigators
Jyoutishman Saikia
AIIMS New Delhi