Breast Cancer
Conditions
Brief summary
This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.
Detailed description
Visits: Screening: Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month. Intervention: In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM). The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes. * All radioactive nodes and / or fluorescent will be deleted * Reports of anatomy fluorescent SN and / or hot Next visit: The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
Interventions
DRUGInfracyanine
In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
Sponsors
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Female age \> 18 years 2. Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal 3. Diagnosis confirmed by biopsy 4. Breast cancer extended in situ 5. First surgical treatment
Exclusion criteria
1. Neoadjuvant chemotherapy or hormone therapy. 2. Multicentric tumor 3. Pregnant patient 4. Ongoing participation in another clinical trial with an investigational drug
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary endpoint is the SN detection rate during surgery by fluorescence, by isotopes, by combining the two. The detection rate is defined by the number of patient | During surgery | The detection rate is defined by the number of patient who at least one axillary sentinel node detected by fluorescence and / or isotope intraoperatively / number of female patients injected. |
Secondary
| Measure | Time frame |
|---|---|
| The time between the incision and removal of the first sentinel node identified | During surgery |
| The sensitivity of indocyanine green compared to the technical reference ( percentage of nodes detected by the isotope and which are also detected by the indocyanine green ) | During surgery |
| The wrong negative rate (number of female patients in whom at least one metastatic sentinel node has been detected by isotope and not by ICG) | During surgery |
| Technical direct cost | during the study |
| Incidence rates of allergic reactions | From screening till 1 month after the surgery |
| Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 ) | From screening till 1 month after the surgery |
Countries
France
Outcome results
None listed