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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06378944
Acronym
INSEAN
Enrollment
15000
Registered
2024-04-23
Start date
2024-01-01
Completion date
2029-01-01
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

lymph node detection, indocyanine green, breast cancer

Brief summary

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.

Detailed description

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.

Interventions

OTHERApplication of green indocyanine colorant

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

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

Sponsors

Omphis Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Number of Sentinel lymph node detected. Scale of numberspatients included from 1 January of 2024 til January 1 2029Number of lymph node detected with Indocyanine green and number of lymph node detected iwth techetium 99. Scale of numbers

Secondary

MeasureTime frameDescription
Number of possitive lymph nodespatients included from 1 January of 2024 til January 1 2029assess 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
surgery time in minutespatients included from 1 January of 2024 til January 1 2029Time in minutes from skin incision to lymp node removal.

Countries

Spain

Contacts

Primary ContactSandra Lopez gordo
sandra.lopezgordo@gmail.com0034660284047
Backup ContactSandra Lopez gordo
sandra.lopezgordo@gmail.com660284047

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026