Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer.

Sentinel Lymph Node Clinical Trial

— FLUOBREAST-2  

Official title:

Analysis of the Cost of Using FLUOrescence in Green of Indocyanine for the Detection of the Sentinel Lymph Node in the Breast Cancer.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05699291
• Other study ID #: 2022-A02271-42
• Status: Recruiting
• Start date: February 23, 2023
• Est. completion date: April 2024

Study information

• Verified date: April 2024
• Source: GCS Ramsay Santé pour l'Enseignement et la Recherche
• Contact: Charlotte NGÔ, MD
• Phone: 664123105
• Email: charlotte.ngo[@]senogyneco.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to analyze the average direct costs of each of these techniques, represented by the costs directly linked to the management of breast cancer, to the surgical intervention and to the techniques evaluated (Indocyanine Green and isotopes) which are: consultations, hospitalizations, resources consumed during the surgical intervention, as well as the time of the patients, transport...

Description:

The main objective is to evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital. The chosen time horizon is up to 1 month post-intervention. The choice of this time horizon corresponds to the usual duration of follow-up for patients who have benefited from one of the sentinel lymph node detection techniques, in order to collect the main post-surgical complications. This is a multicenter, prospective, observational, non-randomized study, aimed at comparing the overall cost of two sentinel lymph node detection techniques (Indocyanine Green and isotope) from a dual perspective (health insurance and hospital).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient aged 18 or over, having given her oral non-objection ;
• Patient with histologically proven breast cancer ;
• Patient eligible for the sentinel lymph node technique by Indocyanine Green or isotopes.

Exclusion Criteria:

• Patient who has expressed her opposition to the use of her medical data ;
• Patient under legal protection, guardianship or curatorship ;
• Pregnant patient ;
• Patient not affiliated to a social security scheme.

Related Conditions & MeSH terms

• Sentinel Lymph Node

Intervention

Other:
• Sentinel node detection technique
Patients cared for by a surgeon for histologically proven breast cancer and for whom an indication for detection of the sentinel lymph node is posed.

Locations

Country	Name	City	State
France	Hôpital privé des Peupliers	Paris

Sponsors (1)

Lead Sponsor	Collaborator
GCS Ramsay Santé pour l'Enseignement et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average direct costs of the two techniques assessed (Indocyanine Green and isotopes)	To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green compared to the technique using isotopes in patients with breast cancer, from the point of view of the health insurance and the hospital.	1 month