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Indocyanine Green (ICG) fluorescence guided sentinel node biopsy for axillary nodal staging in breast cancer

Prospective Study for clinical approval of clinical feasibility of Indocyano Green for Fluorescene Detection of Sentinel Lymph Node and Real-time Lymphography in breast cancer patients

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12609000653268
Enrollment
40
Registered
2009-08-04
Start date
2001-05-01
Completion date
Unknown
Last updated
2020-01-13

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

Conditions

None listed

Interventions

Sentinel lymph node (SLN) biopsy is an accepted method for staging of axillary lymph nodes in patients with early breast cancer. Patients with negative SLN can be spared axillary lamph node dissection (ALND) with a significantly lower incidence of numbness, pain, impaired mobility and delay to return to work compared to ALND. SLN biopsy has been performed using different techniques, i.e. injection of blue dye, radioactive colloid or the combination of both. The average rate of SN identification

Sentinel lymph node (SLN) biopsy is an accepted method for staging of axillary lymph nodes in patients with early breast cancer. Patients with negative SLN can be spared axillary lamph node dissection (ALND) with a significantly lower incidence of numbness, pain, impaired mobility and delay to return to work compared to ALND. SLN biopsy has been performed using different techniques, i.e. injection of blue dye, radioactive colloid or the combination of both. The average rate of SN identification using blue dye and radiocolloids is more than 95%, but results are ranging from 65% to 98%. However, there are concerns about sporadic limited availability and additional cost for radiocolloids that includes a lymphoscintigraphy for improved preoperative orientation for extra-axillary nodes and a handheld gamma probe. Furthermore, there are potential radiation hazards with the use of radiocolloids. There is recent evidence that Indocyanine green (ICG) could be a candidate for fluorescence guided SLN biopsy. ICG is a popular reagent that is clinically approved for the use of intravenous injection and has been applied in ocular arteriography and in the identification of gastric mucosal vessels. The reagent is a 776Da di-sulfonated molecule and shows a NIR fluorescence that has a moderate affinity binding site on human serum albumin. It rarely produces side effects and we observed no allergic reactions during the study. The advantages of both radiocolloid and blue dye could be combined using fluorescent dye for sentinel node detection, namely transcutaneous real-time lymphography, lymphatic and SLN staining and identification of lymphatic abnormalities. This study was performed to investigate the clinical approval of ICG fluorescence imaging for SLN detection. Peritumoreous injection of approximately 10mg ICG (2ml with regard to 5mg/ml) was performed intraoperatively 10 min before transcutaneous real-time lymphography with laser induced fluorescene by a camcorder. After transcutaneous identification of a potential Sentinel Lymph Node (SLN), dissection was proceeded lasting about 5-15min to identify and prepare the SLN. Fluorescence was checked after removal of SLN, SLN was sent to pathology and procedure lasted overal time of about 20-30 min. SLN was performed one time for each patient.

Sponsors

Charite Berlin
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

Inclusion criteria were a histopathological approved diagnosis of breast cancer, tumour diameter <=3cm (preoperative T1/T2) and indication for mastectomy or breast conserving therapy without clinically positive lymph node status

Exclusion criteria

operations and/or radiation of the breast, definite lymph node metastases diagnosed by palpation and ultrasound imaging and age <18y

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026