Identification of sentinel lymph nodes in breast cancer patients through non-invasively and percutaneously fluorescent imaging using ICG

Completed

• Conditions: breast cancer; breast carinoma; 10006291

• Registration Number: NL-OMON49864
• Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2022-01-09
• Results First Posted: 2023-08-01
• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 102

Inclusion Criteria

- Clinically node-negative, invasive early T1 or T2 breast cancer confirmed by
biopsy.
- Preoperative axillary ultrasound to confirm clinical node-negative status.
- Indication for lumpectomy and SLN procedure.
- Written informed consent according to ICH/GCP and national regulations.

Exclusion Criteria

- Patients < 18 years old.
- Mastectomy.
- 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>Identification rate of positive SLNs percutaneously by the fluorescent signal<br /><br>of ICG .</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Identification rate of positive SLNs percutaneously by 99mTc.<br /><br>- Number of lymph nodes identified with ICG and standard 99mTc.<br /><br>- Sensitivity: percentage of patients in whom fluorescent lymph nodes were<br /><br>identified of the total patients with identified sentinel lymph nodes by the<br /><br>standard 99mTc.<br /><br>- False positive rates of ICG and 99mTc.<br /><br>- False negative rates of ICG and 99mTc.<br /><br>- Pathology of SLN found by ICG and 99mTc including micro- and macro metastasis<br /><br>and isolated tumor cells (ITCs).<br /><br>- Intraoperative visualization of the SLN with the camera by ICG and 99mTc<br /><br>before skin incision.<br /><br>- Transit time and detection time.<br /><br>- Complications from ICG and 99mTc, including lymph edema, (wound)infection,<br /><br>bleeding.<br /><br>- Number of adverse events from ICG and 99mTc.</p><br>