Confrontations between the Indocianine green marking method, and the radio-isotopic method for axillar node biopsy in breast cancer.

Clinical, operating, prospective, academy, study of not inferiority of the Green Indocyanine (ICG) marking method, versus the radio-isotopic method, of sentinel nodes in breast.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-000483-42-BE

Enrollment

150

Registered

2016-04-25

Start date

2016-05-19

Completion date

Unknown

Last updated

2025-03-24

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

Conditions

Axillar sentinel node research in Breast Cancer staging.

Interventions

Trade Name: ICG-Pulsion Pharmaceutical Form: Powder for injection INN or Proposed INN: Indocyanin Green CAS Number: 3599-32-4 Other descriptive name: INDOCYANINE GREEN Concentration unit: mg/ml millig

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. More then 18 years old 2. Patient affect by a breast Cancer who is eligible to the sentinel node research, in accord with the Belgium national guideline. 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 50

Exclusion criteria

Exclusion criteria: 1. Pregnancy and lactation. 2. Green indocyanine allergy. 3. Patients not able to understand the study and its organization.

Design outcomes

Primary

Measure	Time frame
Main Objective: To show the not inferiority of the research technique by the fluorescent marker, versus the habitual research technique by the radio isotope tracer, in sentinel node research for breast cancer staging.;Secondary Objective: 1. To show the sensibility and specificity of detection between the two techniques alones. 2. To show the sensibility and specificity of detection between the two techniques together. 3. To report sides effect of green indocyanine, in under skin injection. 4. Analyze the different of price and time between the two techniques. 5. To show the satisfaction rate of the fluorescent technique for surgeons. 6. To show the satisfaction rate of the fluorescent technique for patients. 7. To show the learning curve.;Primary end point(s): Feasibility study of the fluorescent technique for sentinel node research.;Timepoint(s) of evaluation of this end point: 6 month	—

Measure

Time frame

Main Objective: To show the not inferiority of the research technique by the fluorescent marker, versus the habitual research technique by the radio isotope tracer, in sentinel node research for breast cancer staging.;Secondary Objective: 1. To show the sensibility and specificity of detection between the two techniques alones. 2. To show the sensibility and specificity of detection between the two techniques together. 3. To report sides effect of green indocyanine, in under skin injection. 4. Analyze the different of price and time between the two techniques. 5. To show the satisfaction rate of the fluorescent technique for surgeons. 6. To show the satisfaction rate of the fluorescent technique for patients. 7. To show the learning curve.;Primary end point(s): Feasibility study of the fluorescent technique for sentinel node research.;Timepoint(s) of evaluation of this end point: 6 month

—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Belgium

Contacts

Public ContactClinique du Sein

ISPPC - CHU Charleroi - Hopital Civil Marie Curie

luciano.lmc@gmail.com

Outcome results

None listed

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