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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)

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ClinicalTrials.gov Identifier: NCT02279108
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : April 9, 2018
Last Update Posted : April 9, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

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.


Condition or disease Intervention/treatment Phase
Breast Neoplasms Drug: indocyanine green Drug: isotope Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : November 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: double detection Indocyanine + isotope
intradermal injection of 2.5 milligrams of indocyanine green and 20 MBq of technetium 99 before breast surgery
Drug: indocyanine green
One injection, 2.5 milligrams per patient, intradermal use

Drug: isotope
One injection, 20 MBq techntium99, intradermal use
Other Name: technetium

Active Comparator: isotope detection alone
intradermal injection of 20 MBq of technetium 99 before breast surgery
Drug: isotope
One injection, 20 MBq techntium99, intradermal use
Other Name: technetium




Primary Outcome Measures :
  1. Number of Patients With Less Than Two Lymph Nodes Detected [ Time Frame: peroperative ]
    Number of patients with less than two lymph nodes detected by indocyanine (ICG) + isotope versus isotope detection alone


Secondary Outcome Measures :
  1. Number of Lymph Nodes ICG Positive and Tc Positive [ Time Frame: Peroperative ]
    Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium)positive

  2. Number of Lymph Nodes ICG Positive and Tc Negative [ Time Frame: Peroperative ]
    Number of lymph nodes Indocyanine green (ICG) positive and Tc (Technetium) negative

  3. Number of Lymph Nodes ICG Negative and Tc Positive [ Time Frame: Peroperative ]
    Number of lymph nodes Indocyanine green (ICG) negative and Tc (Technetium) positive

  4. Comparison Between Groups of the Time of the Surgery [ Time Frame: Peroperative ]
    time from incision to wound closure

  5. Comparison Between Groups of Anesthesia Time [ Time Frame: Peroperative ]
    time from the injection of anesthesic to the waking

  6. Time From Injection of One Dose ICG Injection to Incision Time [ Time Frame: Peroperative ]
    time from injection of one dose ICG injection to incision time

  7. Comparison Between Groups of Time Surgery Node [ Time Frame: Peroperative ]
    time from incision time to the last node surgery

  8. Number of Patients With ICG Allergy [ Time Frame: peroperative ]
    allergy is : redness, edema, itching, larynges edema and/or allergic shock

  9. Number of Patients With ICG Allergy [ Time Frame: 1 hour after the end of the surgery ]
    allergy is : redness, edema, itching, larynges edema and/or allergic shock

  10. Number of Patients With ICG Allergy [ Time Frame: Month 2 ]
    allergy is : redness, edema, itching, larynges edema and/or allergic shock



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02279108


Locations
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France
Centre Hospitalier Universitaire de Saint-Etienne
Saint-Etienne, France, 42055
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Céline CHAULEUR, PhD Centre Hospitalier Universitaire de Saint Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02279108    
Other Study ID Numbers: 1408153
2014-004005-32 ( EudraCT Number )
First Posted: October 30, 2014    Key Record Dates
Results First Posted: April 9, 2018
Last Update Posted: April 9, 2018
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
sentinel lymph node
indocyanine green
fluorescence method
radioisotope conventional method
breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases