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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Infracyanine

• Registration Number: NCT02875626
• Lead Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

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.

Study Timeline

• Study First Submitted: 2016-08-18
• Study First Submitted QC: 2016-08-22
• Study First Posted: 2016-08-23
• Study Start: 2016-09
• Primary Completion: 2019-02
• Study Completion: 2019-03
• Status Verified: 2019-05
• Last Update Submitted: 2019-07-02
• Last Update Posted: 2019-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Infracyanine	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).

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France