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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.
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.
Next visit:
The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infracyanine | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infracyanine | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. | During surgery |
| Measure | Description | 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 ) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Charlotte NGO, MD | Hôpital Européen Georges-Pompidou | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Européen Georges Pompidou | Paris | 75015 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33094498 | Derived | Ngo C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lecuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22. |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C116320 | Infracyanine green |
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|
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |