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

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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003828-21-NL

Enrollment

100

Registered

2020-01-21

Start date

2020-02-10

Completion date

Unknown

Last updated

2023-08-21

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

Conditions

Axillar staging in breast cancer patients

Interventions

Trade Name: Indocyanine Green (VERDYE) Product Name: INDOCYANINE GROEN Pharmaceutical Form: Powder and solvent for solution for injection

Eligibility

Sex/Gender

All

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. 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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care radioisotope technetium (99mTc) in the SLN procedure for breast cancer patients;Secondary Objective: To assess the: -sensitivity of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -false negatives of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -false positive rate between ICG method and 99mTc method to identify the SLN in breast cancer -number of SLN identified with ICG compared to the standard 99mTc. -the difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastasis (Mic and Mac resp.) 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 for the use of ICG to detect de SLN -complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -number of adverse events from the combination of ICG and 99mTc;Primary end point(s): - Identification rate of SLNs by the fluorescent signal of ICG and by 99mTc.;Timepoint(s) of evaluation of this end point: Peroperatively	—

Measure

Time frame

Main Objective: to identify the diagnostic value of indocyanine green (ICG) fluorescence imaging for SLN mapping versus the standard-of-care radioisotope technetium (99mTc) in the SLN procedure for breast cancer patients;Secondary Objective: To assess the: -sensitivity of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -false negatives of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -false positive rate between ICG method and 99mTc method to identify the SLN in breast cancer -number of SLN identified with ICG compared to the standard 99mTc. -the difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastasis (Mic and Mac resp.) 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 for the use of ICG to detect de SLN -complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in breast cancer. -number of adverse events from the combination of ICG and 99mTc;Primary end point(s): - Identification rate of SLNs by the fluorescent signal of ICG and by 99mTc.;Timepoint(s) of evaluation of this end point: Peroperatively

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Secondary

Measure	Time frame
Secondary end point(s): - Number of lymph nodes identified with ICG and standard 99mTc. - Percentage of patients in whom fluorescent SLNs were identified of the total patients with identified SLNs by the standard 99mTc. - Percentage of SLNs that is fluorescent, but not positive for 99mTc. - Percentage of SLNs that are not fluorescent but positive for 99mTc. - Pathology of SLN found by ICG and 99mTc including micro- and macro metastasis and isolated tumor cells (ITCs). - Percutaneous intraoperative visualization of the SLN and lymph drainage with the camera by ICG before skin incision: yes, weak, no; only lymph vessel, no both lymph vessel and node are not visible. - Detection time: average time between skin incision and SLN resection in minutes. - Complication rates from the SN procedure by ICG and 99mTc, including lymph edema, (wound)infection, (temporarily) skin discoloring, bleeding and a mild allergic reaction. - Number of serious adverse events from ICG and 99mTc, including severe allergic reaction, death or other serious adverse events.;Timepoint(s) of evaluation of this end point: Peroperatively or when pathology report is definitive (i.e., 1 week later) or during follow-up appointment (i.e., 1 week later)	—

Measure

Time frame

Secondary end point(s): - Number of lymph nodes identified with ICG and standard 99mTc. - Percentage of patients in whom fluorescent SLNs were identified of the total patients with identified SLNs by the standard 99mTc. - Percentage of SLNs that is fluorescent, but not positive for 99mTc. - Percentage of SLNs that are not fluorescent but positive for 99mTc. - Pathology of SLN found by ICG and 99mTc including micro- and macro metastasis and isolated tumor cells (ITCs). - Percutaneous intraoperative visualization of the SLN and lymph drainage with the camera by ICG before skin incision: yes, weak, no; only lymph vessel, no both lymph vessel and node are not visible. - Detection time: average time between skin incision and SLN resection in minutes. - Complication rates from the SN procedure by ICG and 99mTc, including lymph edema, (wound)infection, (temporarily) skin discoloring, bleeding and a mild allergic reaction. - Number of serious adverse events from ICG and 99mTc, including severe allergic reaction, death or other serious adverse events.;Timepoint(s) of evaluation of this end point: Peroperatively or when pathology report is definitive (i.e., 1 week later) or during follow-up appointment (i.e., 1 week later)

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Countries

Netherlands

Contacts

Public ContactPhD Candidate

St Antonius hospital

c.bargon@antoniusziekenhuis.nl

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026