Identification of SLN in breast cancer patients using ICG – INFLUENCE II study

Identification of the sentinel lymph node in breast cancer patients through non-invasively fluorescent imaging using indocyanine green: an international multicenter implementation study - INFLUENCE II study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55958

Enrollment

493

Registered

2022-09-01

Start date

2023-05-30

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Breast cancer, breast carcinoma

Interventions

Phase I (pre-implementation) The standard of care SLN procedure will be performed, which implies 99mTc injection, the day or the morning before surgery. Study outcomes will be registered during SN-p

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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), radioisotope technetium (99mTc), intravenous contrast or iodine. - 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.

Design outcomes

Secondary

Measure	Time frame
Secondary Objectives: To assess: - The median number of SLN identified - Percentage of SLNs that has 99mTc uptake/ is fluorescent - The pathology of SLNs found by localization method, including micro- and macro metastases and isolated tumor cells (ITCs) - The detection time, defined as time between skin incision and SLN resection in minutes - Duration of the SN-procedure - Duration of the total surgical procedure - Complications, including seroma, wound infection and bleeding - The number of serious adverse events - Duration of the total procedure - Locoregional recurrence after 1 year follow-up To describe: - (Pre-implementation) expectations regarding ICG - (Post-implementation) experiences regarding ICG including success factors and barriers. - The process of the learning curve To provide: - National guidelines for ICG implementation	—

Measure

Time frame

Secondary Objectives: To assess: - The median number of SLN identified - Percentage of SLNs that has 99mTc uptake/ is fluorescent - The pathology of SLNs found by localization method, including micro- and macro metastases and isolated tumor cells (ITCs) - The detection time, defined as time between skin incision and SLN resection in minutes - Duration of the SN-procedure - Duration of the total surgical procedure - Complications, including seroma, wound infection and bleeding - The number of serious adverse events - Duration of the total procedure - Locoregional recurrence after 1 year follow-up To describe: - (Pre-implementation) expectations regarding ICG - (Post-implementation) experiences regarding ICG including success factors and barriers. - The process of the learning curve To provide: - National guidelines for ICG implementation

—

Primary

Measure	Time frame
To evaluate the effectiveness of Indocyanine Green (ICG) for sentinel lymph biopsies in breast cancer patients.	—

Countries

Italy, Netherlands

Contacts

Public ContactT.L. Dinger

St. Antonius Ziekenhuis

t.dinger@antoniusziekenhuis.nl0681252249

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)