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

NCT02875626 | Completed

• 1 other identifier: FLUOBREAST
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The time between the incision and removal of the first sentinel node identified

  During surgery

• 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

• Technical direct cost

  during the study

• Incidence rates of allergic reactions

  From screening till 1 month after the surgery

Study Arms (1)

Infracyanine

EXPERIMENTAL

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).

Drug: Infracyanine

Interventions

Infracyanine DRUG

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).

Also known as: indocyanin green

Infracyanine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female age \> 18 years
• Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
• Diagnosis confirmed by biopsy
• Breast cancer extended in situ
• First surgical treatment

You may not qualify if:

• Neoadjuvant chemotherapy or hormone therapy.
• Multicentric tumor
• Pregnant patient
• Ongoing participation in another clinical trial with an investigational drug

Sponsors & Collaborators

• Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie: lead

Study Sites (1)

Hôpital Européen Georges Pompidou

Paris, 75015, France

Location

Related Publications (1)

• Ngo C, Sharifzadehgan S, Lecurieux-Lafayette C, Belhouari H, Rousseau D, Bonsang-Kitzis H, Crouillebois L, Balaya V, Oudard S, Lecuru F, Elaidi RT. Indocyanine green for sentinel lymph node detection in early breast cancer: Prospective evaluation of detection rate and toxicity-The FLUOBREAST trial. Breast J. 2020 Dec;26(12):2357-2363. doi: 10.1111/tbj.14100. Epub 2020 Oct 22.

  PMID: 33094498 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Infracyanine green

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Charlotte NGO, MD

  Hôpital Européen Georges-Pompidou

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: September 1, 2016
• Primary Completion: February 1, 2019
• Study Completion: March 1, 2019
• Last Updated: July 5, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)