Is using a single tracer to identify lymph nodes during breast cancer surgery as good as using two tracers?

Not Applicable

Completed

• Conditions: Identification of sentinel lymph nodes during breast cancer surgery; Cancer

• Registration Number: ISRCTN12010145
• Lead Sponsor: HS Tayside

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-12-08
• Study Completion: 2023-03-31
• Last Update Posted: 22 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 100

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

1. Neoadjuvant chemotherapy
2. Prior ipsilateral axillary surgery or breast excision biopsy
3. Pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Successful identification of the sentinel lymph node using a physical examination on Day 1

Secondary Outcome Measures

Name	Time	Method
1. Tumour deposits in at least one node measured using a pathology evaluation on Day 1<br>2. Seroma formation measured using a physical examination at 2 weeks and 3 months<br>3. Cutaneous staining measured using a physical examination at 2 weeks and 3 months<br>4. Other adverse reactions to tracers measured using a physical examination at 2 weeks and 3 months