Clinical trial NCT02875626: Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer
Official title: Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: During surgery
Secondary outcomes:
measure: The time between the incision and removal of the first sentinel node identified
timeFrame: During surgery
measure: 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 )
timeFrame: During surgery
measure: 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)
timeFrame: During surgery
measure: Technical direct cost
timeFrame: during the study
measure: Incidence rates of allergic reactions
timeFrame: From screening till 1 month after the surgery
measure: Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
timeFrame: From screening till 1 month after the surgery
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Européen Georges Pompidou
Study officials:
affiliation: Hôpital Européen Georges-Pompidou
name: Charlotte NGO, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.