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NCT Number: NCT06378944

Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer

The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer, indocyanine green. The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique.

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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–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Sandra Lopez Gordo

Cerdanyola del Vallès, Barcelona, 08290, Spain

Location status: Recruiting

Location contact

Sandra Lopez gordo

CONTACT

[email protected]

660284047

About this study

In the operating room 1 ml of indocyaninge grenn will be injectec periareolar . After 5 minutes the lymph node will be detected and extracted. The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients >18 years of age with breast cancer who are candidates for sentinel lymph node detection will be included.
  • N0 patients or patients who have undergone target axillary detection with good response

Exclusion criteria

  • Lymphadenectomy

Treatment and study plan

Application of green indocyanine colorant

Other

The day of the surgery 1 ml of green indocyanine colorant will be applicated periareolar. After 5 minutes the lymph node will be detected and extracted

Technetium99

Drug

Application of a periareolar injectionof TEchnetium 99 in order to detect the axillary lymph node

Primary outcomes

  1. Number of Sentinel lymph node detected. Scale of numbers

    Time frame: patients included from 1 January of 2024 til January 1 2029

    Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers

Secondary outcomes

  1. Number of possitive lymph nodes

    Time frame: patients included from 1 January of 2024 til January 1 2029

    assess whether there are differences in affected lymph nodes detected with indocyanine green or technetium 99 Number of possitive lymph nodes iwh indocyanine green and with technetium 99

  2. surgery time in minutes

    Time frame: patients included from 1 January of 2024 til January 1 2029

    Time in minutes from skin incision to lymp node removal.

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Lopez gordo

CONTACT

[email protected]

0034660284047

Sandra Lopez gordo

CONTACT

[email protected]

660284047

Sponsors and collaborators

Lead sponsor

Omphis Foundation

Other

Registry information

Official study title

INDOCYANINE GREEN for SELECTIVE SENTINELLA AXILLARY LYMPH NODE BIOPSY in PATIENTS with BREAST CANCER

Acronym: INSEAN

Important dates

Study start
2024
Primary completion
2029
Study completion
2029
First posted
Apr 23, 2024
Registry last updated
Sep 19, 2024

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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