Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG for breast cancer patients.
Conditions
Interventions
Trade Name: ICG Pulsion
Pharmaceutical Form: Powder for solution for injection
CAS Number: 3599-32-4
Other descriptive name: INDOCYANINE GREEN
Concentration unit: mg milligram(s)
Concentration type: e
Sponsors
Jules Bordet Institute
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Female patients with cT2N0M0 unifocal breast cancer where SLN may be proposed. - General operability. 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 214 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Age less than18 years old. - Multifocal cancer - Former operation in the axilla and/or breast. - Any previous radiotherapy at the concerned breast and/or axilla and/or chest wall. - Definite lymph node metastases. - History of allergy or hypersensitivity against the investigational product (its active substance or ingredients), to iodine or to shellfish. - Apparent hyperthyroidism, autonomous thyroid adenoma, unifocal, multifocal or dissemi-nated autonomies of the thyroid gland. - Documented coronary disease. - Advanced renal impairment (creatinine > 1,5mg/dl). - During the 2 weeks before the enrolment, concurrent medication which reduces or increases the extinction of ICG (i.e. anticonvulsants, haloperidol and Heparin). - Pregnancy, breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives: - Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG. - These results will be compared to those with the (our) classical intra-mammary and peri-tumoral injections of 99mTc-HSA-Nanocolloids. - Evaluation of their complementarity. ;Secondary Objective: - Evaluation of the time during which ICG will remain visible-detectable in women with tumorectomy at the level of the injections sites. - In women with/after tumorectomy, study of the axillary liquids: frequency of the ICG detection in these liquids, duration of this detection, analysis of these liquids (ICG free and/or bound to proteins and/or cells,…) - In women with tumorectomy, study of the immediate post-operative period modifications of the lymphatic drainage from the peri-areolar injected sites. ;Primary end point(s): Primary objectives: - Determination of the detection rate, false negative rate and overall accuracy of the sentinel lymph nodes approach using subcutaneous and peri-areolar injections of ICG. - These results will be compared to those with the (our) classical intra-mammary and peri-tumoral injections of 99mTc-HSA-Nanocolloids. - Evaluation of their complementarity. ;Timepoint(s) of evaluation of this end point: End of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Evaluation of the time during which ICG will remain visible-detectable in women with tumorectomy at the level of the injections sites. - In women with/after tumorectomy, study of the axillary liquids: frequency of the ICG detection in these liquids, duration of this detection, analysis of these liquids (ICG free and/or bound to proteins and/or cells,…) - In women with tumorectomy, study of the immediate post-operative period modifications of the lymphatic drainage from the peri-areolar injected sites. ;Timepoint(s) of evaluation of this end point: End of the study. | — |
Countries
Belgium
Contacts
Public ContactProf. Bourgeois
Jules Bordet Institute
Outcome results
None listed