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

July 2, 2019 updated by: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Hopital Europeen Georges Pompidou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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).
Drug: 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).
Other Names:
  • indocyanin green

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 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.
During surgery

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Investigators

  • Principal Investigator: Charlotte NGO, MD, Hopital Europeen Georges-Pompidou

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Actual)

February 1, 2019

Study Completion (Actual)

March 1, 2019

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

July 5, 2019

Last Update Submitted That Met QC Criteria

July 2, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FLUOBREAST

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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