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Completed

NCT Number: NCT02875626

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Européen Georges Pompidou

Paris, 75015, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Infracyanine

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. The time between the incision and removal of the first sentinel node identified

    Time frame: During surgery

  2. 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

  3. 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

  4. Technical direct cost

    Time frame: during the study

  5. Incidence rates of allergic reactions

    Time frame: From screening till 1 month after the surgery

  6. Severity of allergic reactions (grade 1 to 5 according to Ring and al 38 )

    Time frame: From screening till 1 month after the surgery

Sponsors and collaborators

Lead sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Aug 23, 2016
Registry last updated
Jul 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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