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Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer (FLUOTECH)

Primary Purpose

Breast Neoplasms

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
indocyanine green
isotope
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Neoplasms focused on measuring sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…)
  • Unifocal or multifocal but in same quarter
  • Size < 5cm clinically palpable or not
  • Clinically or ultrasound axillary N0
  • Isotopic sentinel node detection
  • Adult patient
  • Signed informed consent by patient or legally responsable authority
  • Patient registered to a social security system
  • No surgical contra-indication

Exclusion Criteria:

  • Mammary carcinoma recurrence
  • Previous same side mammary reduction
  • Previous lumpectomy
  • Contra-indication to surgery
  • Pregnant or breast feeding patient
  • Denial of participation

Sites / Locations

  • Centre Hospitalier Universitaire de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

double detection Indocyanine + isotope

isotope detection alone

Arm Description

intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery

intradermal injection of 20 MBq of technetium 99 before breast surgery

Outcomes

Primary Outcome Measures

Number of Patients With Less Than Two Lymph Nodes Detected
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone

Secondary Outcome Measures

Number of Lymph Nodes ICG Positive and Tc Positive
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Number of Lymph Nodes ICG Positive and Tc Negative
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Number of Lymph Nodes ICG Negative and Tc Positive
Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Comparison Between Groups of the Time of the Surgery
time from incision to wound closure
Comparison Between Groups of Anesthesia Time
time from the injection of anesthesic to the waking
Time From Injection of One Dose ICG Injection to Incision Time
time from injection of one dose ICG injection to incision time
Comparison Between Groups of Time Surgery Node
time from incision time to the last node surgery
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Number of Patients With ICG Allergy
allergy is : redness, edema, itching, larynges edema and/or allergic shock

Full Information

First Posted
October 27, 2014
Last Updated
September 5, 2017
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT02279108
Brief Title
Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Acronym
FLUOTECH
Official Title
Comparative, Prospective, Randomized Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
November 2014 (Actual)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
July 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The sentinel node has a fundamental role in the management of early breast cancer. Currently, the double detection of blue and radioisotope is recommended. A radioactive material requires the presence of a nuclear medicine department and the approval of health authorities. In many centers, this technique is not available. The use of blue is easier to implement technique. However, allergic reactions and prolonged breast tattoo led many teams to stop the practice. So in common practice, many center use a single method. However, with a single detection, the risk of false negatives and the identification failure rate increased to a significant extent and the number of sentinel lymph node detected and removed is not enough. Under these conditions, find another method of detection seems crucial. According to the literature, the fluorescence method (ICG) is a technique that seems safe and reliable. The investigators therefore propose a prospective, randomized study to investigate the interest of fluorescence associated with the isotopic method.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
Keywords
sentinel lymph node, indocyanine green, fluorescence method, radioisotope conventional method, breast cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
double detection Indocyanine + isotope
Arm Type
Experimental
Arm Description
intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
Arm Title
isotope detection alone
Arm Type
Active Comparator
Arm Description
intradermal injection of 20 MBq of technetium 99 before breast surgery
Intervention Type
Drug
Intervention Name(s)
indocyanine green
Intervention Description
One injection, 2.5 milligrams per patient, intradermal use
Intervention Type
Drug
Intervention Name(s)
isotope
Other Intervention Name(s)
technetium
Intervention Description
One injection, 20 MBq techntium99, intradermal use
Primary Outcome Measure Information:
Title
Number of Patients With Less Than Two Lymph Nodes Detected
Description
Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone
Time Frame
peroperative
Secondary Outcome Measure Information:
Title
Number of Lymph Nodes ICG Positive and Tc Positive
Description
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive
Time Frame
Peroperative
Title
Number of Lymph Nodes ICG Positive and Tc Negative
Description
Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative
Time Frame
Peroperative
Title
Number of Lymph Nodes ICG Negative and Tc Positive
Description
Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive
Time Frame
Peroperative
Title
Comparison Between Groups of the Time of the Surgery
Description
time from incision to wound closure
Time Frame
Peroperative
Title
Comparison Between Groups of Anesthesia Time
Description
time from the injection of anesthesic to the waking
Time Frame
Peroperative
Title
Time From Injection of One Dose ICG Injection to Incision Time
Description
time from injection of one dose ICG injection to incision time
Time Frame
Peroperative
Title
Comparison Between Groups of Time Surgery Node
Description
time from incision time to the last node surgery
Time Frame
Peroperative
Title
Number of Patients With ICG Allergy
Description
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time Frame
peroperative
Title
Number of Patients With ICG Allergy
Description
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time Frame
1 hour after the end of the surgery
Title
Number of Patients With ICG Allergy
Description
allergy is : redness, edema, itching, larynges edema and/or allergic shock
Time Frame
Month 2

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Histologically proved infiltrating breast cancer (ductal, lobular carcinoma…) or a carcinoma in-situ with an elevated risk of micro-invasion. (High grade with necrosis, radiologically evaluated size more than 40mm, or immediate mastectomy…) Unifocal or multifocal but in same quarter Size < 5cm clinically palpable or not Clinically or ultrasound axillary N0 Isotopic sentinel node detection Adult patient Signed informed consent by patient or legally responsable authority Patient registered to a social security system No surgical contra-indication Exclusion Criteria: Mammary carcinoma recurrence Previous same side mammary reduction Previous lumpectomy Contra-indication to surgery Pregnant or breast feeding patient Denial of participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Céline CHAULEUR, PhD
Organizational Affiliation
Centre Hospitalier Universitaire de Saint Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier Universitaire de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Study Assessing The Interest of Indocyanine Green Fluorescence Imaging With Radioisotope Method For Sentinel Lymph Node Biopsy in Patients With Breast Cancer

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