Indocyanine green guided identification of sentinel lymph nodes via mastectomy incision in breast cancer patients.

Indocyanine green guided identification of sentinel lymph nodes via mastectomy incision in breast cancer patients. - INIGMA study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON57105

Enrollment

Registered

2022-07-05

Start date

2022-08-22

Completion date

Unknown

Last updated

2026-06-29

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

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, DCIS, invasive T1- T3 breast cancer confirmed by biopsy. - Preoperative axillary ultrasound to confirm clinical node-negative status. - Indication (or preference) for mastectomy and simultaneous SLN procedure. - Written informed consent according to ICH/GCP and national regulations.

Exclusion criteria

Exclusion criteria: - Patients

Design outcomes

Primary

Measure	Time frame
- To assess the detection rate of the ICG method to identify the SLN via a mastectomy incision.	—

Secondary

Measure	Time frame
- The detection rate of 99mTc. - The difference in detection rate between ICG and 99mTc. - The median number of SLN identified with ICG and 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. - The difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastases (Mic and Mac resp.) and isolated tumor cells (ITCs). - Detection time for the use of ICG to detect the SLN, defined as time between skin incision and SLN resection in minutes - Complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in mastectomies. - The number of serious adverse events from the combination of ICG and 99mTc.	—

Measure

Time frame

- The detection rate of 99mTc. - The difference in detection rate between ICG and 99mTc. - The median number of SLN identified with ICG and 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. - The difference in pathology of the SLN found by ICG and 99mTc, including the difference between micro- and macro metastases (Mic and Mac resp.) and isolated tumor cells (ITCs). - Detection time for the use of ICG to detect the SLN, defined as time between skin incision and SLN resection in minutes - Complications, including wound infection, bleeding and lymphedema, of the combination of the ICG method and the standard 99mTc method to identify the SLN in mastectomies. - The number of serious adverse events from the combination of ICG and 99mTc.

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 3, 2026