Endometrial CancerFLARESNCT07916610
Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
A study testing Superficial cervical ICG injection and Deep and superficial ICG cervical injection in people with Endometrial Cancer, run by Barretos Cancer Hospital.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Superficial cervical ICG injection and Deep and superficial ICG cervical injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- Allergic reaction of ICG and Iodo
- Previous gynecologic oncology disease
- Previous pelvic radiotherapy
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
Read the 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
- Conditions
- Endometrial Cancer
- Being tested
- Superficial cervical ICG injection, Deep and superficial ICG cervical injection
- Keywords
- uterine cancer
- Medical subject headings
- Endometrial Neoplasms, Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superficial cervical ICG injectionDiagnostic test
Also called Superficial cervical ICG injection for sentinel lymph node mapping
Superficial ICG cervical injections
Deep and superficial ICG cervical injectionDiagnostic test
Deep and superficial ICG cervical injection for sentinel lymph node mapping
| Study group | Role | What they receive |
|---|---|---|
| Superficial cervical ICG injection | Experimental | Superficial cervical ICG injection for sentinel lymph node mapping Receives: Diagnostic Test: Superficial cervical ICG injection |
| Deep and superficial ICG cervical injection | Active comparator | Deep and superficial ICG cervical injection Receives: Diagnostic Test: Deep and superficial ICG cervical injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pelvic bilateral sentinel lymph detection with superficial ICG cervical injection compared to deep and superficial cervical injection
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.
Measured: 12 weeks
Noninferiority of superficial ICG cervical injection for sentinel lymph node detection
The noninferiority of superficial cervical ICG injection compared with combined deep and superficial cervical injection for sentinel lymph node detection will be evaluated.
Measured: From enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionAug 2030 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo dos Reis, Barretos Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916610
- Sponsor's protocol ID
- 00051826.5.1001.5437
- Acronym
- FLARES
- Status last verified
- Nov 2026
- First submitted
- 6 Aug 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Superficial-Only Versus Combined Indocyanine Green Injection Techniques for Sentinel Lymph Node Mapping in Patients With Endometrial Cancer: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07916610
- Acronym / sponsor ID
- FLARES / 00051826.5.1001.5437
- Conditions
- Endometrial Cancer
- Keywords
- uterine cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Aug 2030 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Superficial cervical ICG injection | Experimental | Diagnostic Test: Superficial cervical ICG injectionSuperficial cervical ICG injection for sentinel lymph node mapping |
| Deep and superficial ICG cervical injection | Active comparator | Diagnostic Test: Deep and superficial ICG cervical injectionDeep and superficial ICG cervical injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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).
Key exclusion criteria (3 listed)
- Allergic reaction of ICG and Iodo
- Previous gynecologic oncology disease
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Superficial cervical ICG injectionAlso: Superficial cervical ICG injection for sentinel lymph node mappingSuperficial ICG cervical injections | Diagnostic test | Superficial cervical ICG injection |
| Deep and superficial ICG cervical injectionDeep and superficial ICG cervical injection for sentinel lymph node mapping | Diagnostic test | Deep and superficial ICG cervical injection |
Primary outcome
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Superficial cervical ICG injection and Deep and superficial ICG cervical injection in people with Endometrial Cancer, run by Barretos Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Luis Pires Melo Filho, Dr (1733216600 ext. 7126, luisfilho4@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pelvic bilateral sentinel lymph detection with superficial ICG cervical injection compared to deep and superficial cervical injection (time frame: 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.