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

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Infracyanine
Sponsored by
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Européen Georges Pompidou

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Infracyanine

Arm Description

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The time between the incision and removal of the first sentinel node identified
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 )
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)
Technical direct cost
Incidence rates of allergic reactions
Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )

Full Information

First Posted
August 18, 2016
Last Updated
July 2, 2019
Sponsor
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
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1. Study Identification

Unique Protocol Identification Number
NCT02875626
Brief Title
Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer
Official Title
Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer (FLUO-BREAST)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 2016 (undefined)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Infracyanine
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Infracyanine
Other Intervention Name(s)
indocyanin green
Intervention Description
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).
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
During surgery
Secondary Outcome Measure Information:
Title
The time between the incision and removal of the first sentinel node identified
Time Frame
During surgery
Title
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
Title
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
Title
Technical direct cost
Time Frame
during the study
Title
Incidence rates of allergic reactions
Time Frame
From screening till 1 month after the surgery
Title
Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )
Time Frame
From screening till 1 month after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Neoadjuvant chemotherapy or hormone therapy. Multicentric tumor Pregnant patient Ongoing participation in another clinical trial with an investigational drug
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charlotte NGO, MD
Organizational Affiliation
Hôpital Européen Georges-Pompidou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Européen Georges Pompidou
City
Paris
ZIP/Postal Code
75015
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33094498
Citation
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.
Results Reference
derived

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

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