Confrontations between the Indocianine green marking method, and theradio-isotopic method for axillar node biopsy in breast cancer.
Phase 1
- Conditions
- Axillar sentinel node research in Breast Cancer staging.Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Equipment and Supplies [E07]
- Registration Number
- EUCTR2016-000483-42-BE
- Lead Sponsor
- ISPPCC - CHU Chrarleroi - Hôpital Civil Marie Curie - Clinique du Sein
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
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
1.Pregnancy and lactation.
2.Green indocyanine allergy.
3.Patients not able to understand the study and its organization.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>2. To show the sensibility and specificity of detection between the two techniques together.<br>3. To report sides effect of green indocyanine, in under skin injection. <br>4. Analyze the different of price and time between the two techniques.<br>5. To show the satisfaction rate of the fluorescent technique for surgeons.<br>6. To show the satisfaction rate of the fluorescent technique for patients.<br>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 Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable