Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer

Breast Cancer Clinical Trial

Official title:

Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875626
• Other study ID #: FLUOBREAST
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: March 2019

Study information

• Verified date: May 2019
• Source: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: March 2019
• Est. primary completion date: February 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Infracyanine
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).

Locations

Country	Name	City	State
France	Hôpital Européen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	The time between the incision and removal of the first sentinel node identified		During surgery
Secondary	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
Secondary	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
Secondary	Technical direct cost		during the study
Secondary	Incidence rates of allergic reactions		From screening till 1 month after the surgery
Secondary	Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )		From screening till 1 month after the surgery