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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON49864

Enrollment

100

Registered

2020-01-21

Start date

2020-08-21

Completion date

Unknown

Last updated

2025-08-18

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

Conditions

breast cancer breast carinoma

Interventions

All included patients will receive standard of care implying 99mTc injection the day before surgery. Consequently, 5 mg (2 ml) ICG will be injected periareolar after administration of general anaest

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: - Patients

Design outcomes

Primary

Measure	Time frame
Identification rate of positive SLNs percutaneously by the fluorescent signal of ICG .	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)