Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer (FLARES)

November 1, 2026 updated by: Ricardo dos Reis, Barretos Cancer Hospital

Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer: A Randomized Clinical Trial

This Clinical trial will compare ICG cervical superficial injections versus superficial and deep injection for sentinel lymph node mapping in early-stage endometrial cancer patients

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will compare indocyanine green cervical injection superficial versus superficial and deep injection for sentinel lymph node mapping in early-stage endometrial cancer patients

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

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

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women aged ≥18 years with a confirmed diagnosis of stage I endometrial cancer who underwent sentinel lymph node mapping with ICG at Barretos Cancer Hospital Treated using a minimally invasive approach (laparoscopic or robotic).

Exclusion Criteria:

  • Allergic reaction of ICG and Iodo
  • Previous gynecologic oncology disease
  • Previous pelvic radiotherapy

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

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Superficial cervical ICG injection

Superficial cervical ICG injection for sentinel lymph node mapping
Diagnostic test: Superficial cervical ICG injection

Superficial ICG cervical injections

Other Names:
  • Superficial cervical ICG injection for sentinel lymph node mapping
Active Comparator: Deep and superficial ICG cervical injection

Deep and superficial ICG cervical injection
Diagnostic test: Deep and superficial ICG cervical injection

Deep and superficial ICG cervical injection for sentinel lymph node mapping

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of pelvic bilateral sentinel lymph detection with superficial ICG cervical injection compared to deep and superficial cervical injection
Time Frame: 12 weeks

Our primary objective will be to compare the bilateral pelvic sentinel lymph node detection rates between superficial cervical injection of ICG and combined deep and superficial cervical injection.
12 weeks
Noninferiority of superficial ICG cervical injection for sentinel lymph node detection
Time Frame: From enrollment to the end of treatment at 12 weeks

The noninferiority of superficial cervical ICG injection compared with combined deep and superficial cervical injection for sentinel lymph node detection will be evaluated.
From enrollment to the end of treatment at 12 weeks

Collaborators and Investigators

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

Sponsor

Barretos Cancer Hospital

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 (Estimated)

December 1, 2026

Primary Completion (Estimated)

August 1, 2030

Study Completion (Estimated)

December 1, 2030

Study Registration Dates

First Submitted

August 6, 2026

First Submitted That Met QC Criteria

November 1, 2026

First Posted (Actual)

November 4, 2026

Study Record Updates

Last Update Posted (Actual)

November 4, 2026

Last Update Submitted That Met QC Criteria

November 1, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00051826.5.1001.5437

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

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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