A feasibility study of indocyanine green (ICG) fluorescence mapping for sentinel lymph node detection in early breast cancer - ICG10

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2009-016743-18-GB

Enrollment

100

Registered

2010-06-28

Start date

2010-02-02

Completion date

Unknown

Last updated

2019-06-30

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

Conditions

Primary breast cancer

Interventions

Trade Name: ICG-PULSION Product Name: Indocyanine Green Pharmaceutical Form: Powder for injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - biopsy proven invasive breast cancer in women over 18. - tumours measuring =65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - history of previous breast cancer - women unable to provide informed consent - prior axillary surgery or a diagnostic excision biopsy of the breast - pregnant or lactating women - hypersensitivity to indocyanine green or to sodium iodide - hypersensitvity to iodine - patients with hyperthyroidism or patients with toxic thyroid adenomas - unable to give written informed consent

Design outcomes

Primary

Measure	Time frame
Main Objective: The principal research question is to assess the sensitivity of ICG for SLNB detection in early breast cancer alone and in combination with radio-isotope and/or blue dye. ;Secondary Objective: A secondary aim of this study is to evaluate in how many patients the sentinel node(s) can be visualised with axillary ultrasound following injection of ICG.;Primary end point(s): Sensitivity of ICG fluorescence imaging for SLNB detection in early breast cancer.	—

Measure

Time frame

Main Objective: The principal research question is to assess the sensitivity of ICG for SLNB detection in early breast cancer alone and in combination with radio-isotope and/or blue dye. ;Secondary Objective: A secondary aim of this study is to evaluate in how many patients the sentinel node(s) can be visualised with axillary ultrasound following injection of ICG.;Primary end point(s): Sensitivity of ICG fluorescence imaging for SLNB detection in early breast cancer.

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Countries

United Kingdom

Outcome results

None listed

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