Radioguided Occult Lesion Localisation by Indocyanine Green
Condition: Breast Cancer Female
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Breast cancer is the most common cancer in women. It is the main cause of cancer deaths among
      women. The incidence of non-palpable tumors is estimated at 60%. Their better prognosis and
      their small size encourage the investigators for finding methods simpler and more efficient
      to treat them by breast-conserving surgery with acceptable cosmetic results.

      The pre-operative detection of the tumor lesion is currently carried out by two methods: the
      radioactive seed localization and guidewire technique. Each has its disadvantages: the
      guidewire is uncomfortable for the patients (pain, hematomes..), whereas the radiocolloid
      requires a specialized and complex organization around this radioactive product.

      Recently, a novel method of using indocyanine green (ICG) fluorescence has been described in
      breast cancer and seems promising.

      In this study, investigators evaluate the feasibility and performance of indocyanine green
      fluorescence in non-palpable tumor detection in comparison with radioactive seed localization
      (ROLL)

      Secondary objectives are evaluate the feasibility of the location by the radiologist,
      feasibility of detection by the surgeon, study of the product and the probe.
    

Detailed description: 
      The study is prospectively conducted during six months of 2017-2018 in the department of
      gynaecology of Montpellier .

      This study includes ten women. Patients will receive both techniques: indocyanine green
      fluorescence (experimental technique) and radiocolloid (reference technique).

      Inclusion will be during the preoperative consultation after checking the inclusion / non
      inclusion criteria and signing a written consent.

      Radioactive localization with technetium will be done on surgery eve like usual. Fluorescence
      localization with ICG will be done in the operating room under general anesthesia by the
      radiologist under ultrasound.

      By a probe (Euromedical instruments), surgeon identified and marked the site of the skin by
      observing the area of the ICG fluorescence. Then, in the same way, the surgeon marked the
      tumor by the radioactive probe detecting the radioactive signal.

      An picture will be made of these two markers and it will be noted the distance between them.
      Dissection and excision of the tumor using the radiocolloid probe (no modification of
      surgical management). At the end of the surgical procedure, verification of no residual
      radioactivity and no residual fluorescence. Again, surgeon identified and marked in the
      excised sample the area of fluorescence and radioactive. The pathological examination of the
      resected specimen will describe positions of mark compared tumor.

      The following data were recorded prospectively: demographics, medical history, localization
      of tumor, surgery, pathology results.
    

Intervention name(s): detection of the tumor lesion
Intervention type(s): Procedure
Intervention description(s): non palpable tumor detection with indocyanine green fluorescence and radioactive seed localization
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention