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

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

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...

Study Overview

• Status: Completed
• Conditions: Sentinel Lymph Node
• Intervention / Treatment: Other: Sentinel node detection technique

Detailed 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).

• Study Type: Observational
• Enrollment (Actual): 163

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hopital Prive des Peupliers

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with histologically proven breast cancer, eligible for sentinel lymph node technique by Indocyanine Green or isotopes

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patient eligible for the sentinel lymph node technique by lndocyanine Green.; 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.	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.
Patient eligible for the sentinel lymph node technique by isotopes.; 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: GCS Ramsay Santé pour l'Enseignement et la Recherche

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2023
• Primary Completion (Actual): May 17, 2024
• Study Completion (Actual): May 17, 2024

Study Registration Dates

• First Submitted: January 16, 2023
• First Submitted That Met QC Criteria: January 16, 2023
• First Posted (Actual): January 26, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2024
• Last Update Submitted That Met QC Criteria: June 4, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2022-A02271-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No