Sentinel lymph node procedure in breast cancer patients through fluorescent green imaging

Phase 1

• Conditions: Axillar staging in breast cancer patients; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

• Registration Number: EUCTR2019-003828-21-NL
• Lead Sponsor: St Antonius Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-21
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 100

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 100

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 clinical trial of medicinal product
• Study Design: Not specified