Identification of the sentinel lymph node in breast cancer patients through non-invasively fluorescent imaging using Indocyanine Green: an international multicenter implementation study.

Recruiting

• Conditions: Breast cancer; breast carcinoma; 10006291

• Registration Number: NL-OMON55958
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 447

Inclusion Criteria

- Clinically node-negative, DCIS or invasive breast cancer confirmed by biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication for SLN procedure via axillary excision
- Written informed consent according to ICH/GCP and national regulations.

Exclusion Criteria

- Patients < 18 years old.
- SN-procedure via mastectomy incision
- Combined MARI procedure
- History of axillary lymph node dissection
- Known allergy for indocyanine green (ICG) or radioisotope technetium (99mTc)
or intravenous contrast, iodine, shellfish.
- Other concurrent solid tumor.
- Hyperthyroidism or thyroid cancer.
- Palliative surgery for locally advanced breast cancer (cT4).
- Pregnancy or breast feeding.
- Psychological, familial, sociological or geographical factors that could
potentially hamper compliance with the
study protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the effectiveness of Indocyanine Green (ICG) for sentinel lymph<br /><br>biopsies in breast cancer patients.</p><br>