Identification of sentinel lymph nodes during breast cancer surgery Cancer
Conditions
Interventions
Participants will be identified from the breast cancer services at each site. Once consented, participants will be randomised using sealed opaque envelopes to receive either standard care or intervent
Sponsors
NHS Tayside
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female 2. Aged over 18 years 3. Biopsy-proven invasive breast cancer 4. Tumour(s) measuring <5 cm in radiological size 5. No record of clinical or sonographic evidence of abnormal axillary lymph nodes 6. Planned SLN biopsy to be carried out as per local standard care using ICG plus radioactive tracer (Cambridge only) or ICG plus Patent Blue Dye (Tayside only)
Exclusion criteria
Exclusion criteria: 1. Neoadjuvant chemotherapy 2. Prior ipsilateral axillary surgery or breast excision biopsy 3. Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Successful identification of the sentinel lymph node using a physical examination on Day 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Tumour deposits in at least one node measured using a pathology evaluation on Day 1 2. Seroma formation measured using a physical examination at 2 weeks and 3 months 3. Cutaneous staining measured using a physical examination at 2 weeks and 3 months 4. Other adverse reactions to tracers measured using a physical examination at 2 weeks and 3 months | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed