Sentinel Lymph Node Detection Using Fluorescein Dye in Breast Cancer

Intraoperative Sentinel Lymph Node Detection Using Fluorescein in Breast Cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0002377

Enrollment

Registered

2017-07-14

Start date

2017-06-07

Completion date

Unknown

Last updated

2019-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : Name: Fluorescite10&#37

Injection (Fluorescein Sodium 500) 1:5 Dose and frequency: 4mL (1mL x 4 sites) Name: Technetium 99m sulfur colloid 1mL Dose and frequency: 1mL (0.25mL x 4 sites) Injection route: areolar, intraderm

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Patients with breast cancer who needs sentinel lymph node biopsy during operation

Exclusion criteria

Exclusion criteria: 1. Patients who does not need sentinel lymph node biopsy because of biopsy proven metastatic lymph nodes 2. Any medical condition or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for this study 3. Hypersensitivity to fluorescein solution 4. Having a heart condition, feeling chest pain during physical activity, experiencing chest pain, becoming dizzy/ever losing balance or consciousness 5. Being pregnant or breastfeeding 6. Having a general weakness

Design outcomes

Primary

Measure	Time frame
Detection rate of sentinel lymph nodes when using 10% Fluorescein and Technetium 99m sulfurcolloid	—

Secondary

Measure	Time frame
Correlation between brightness of sentinel lymph nodes dyed by 10% fluorescein and radioactive score of technetium 99m sulfurcolloid, side effects	—

Countries

Korea, Republic of

Contacts

Public ContactYoung Woo Chang

Korea University Ansan Hospital

ywoochang@gmail.com+82-31-412-4827

Outcome results