Cost of Using FLUOrescence to Green of Indocyanine for the Detection of Breast Cancer. (FLUOBREAST-2)

GCS Ramsay Santé pour l'Enseignement et la Recherche

Status: Completed

Conditions: Sentinel Lymph Node

Treatments: Other: Sentinel node detection technique

Study type: Observational

Funder types: Other

Identifiers

NCT05699291

2022-A02271-42

Details and patient eligibility

About

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...

Full 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).

Enrollment: 163 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

163 participants in 2 patient groups

Patient eligible for the sentinel lymph node technique by lndocyanine Green.

Description:

To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using Indocyanine Green in patients with breast cancer, from the point of view of the health insurance and the hospital.

Treatment:

Other: Sentinel node detection technique

Patient eligible for the sentinel lymph node technique by isotopes.

Description:

To evaluate the overall cost at 1 month of the sentinel lymph node detection technique using isotopes in patients with breast cancer, from the point of view of health insurance and the hospital.

Treatment:

Other: Sentinel node detection technique