Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast Cancer (INSEAN)

April 22, 2024 updated by: Sandra Lopez Gordo, Omphis Foundation

Selective Sentinella Lymph Node Biopsy With Indocyanine Green in Patients With Breast.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

15000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Barcelona
      • Cerdanyola Del Valles, Barcelona, Spain, 08290

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Any patient with breast cancer who recieve surgery and required to perform lymph node detection

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients included from 1 January of 2024 til January 1 2029

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
patients included from 1 January of 2024 til January 1 2029
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.
patients included from 1 January of 2024 til January 1 2029

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Omphis Foundation

Investigators

  • Study Director: Sandra Lopez gordo, 46873584K

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Study Registration Dates

First Submitted

April 1, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 23, 2024

Study Record Updates

Last Update Posted (Actual)

April 23, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 61/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

With REDCap program this study will allow to participated diferents institutions (Hospitals) in Spain

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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