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Not yet recruitingNCT07916610FLARESUpdated Nov 4, 2026

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

An interventional study of Superficial cervical ICG injection and Deep and superficial ICG cervical injection in Endometrial Cancer, sponsored by Barretos Cancer Hospital. Not yet recruiting. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-04.

Sponsored by Barretos Cancer Hospital · Not applicable, Interventional, and Diagnostic

Updated Nov 4, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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 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

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Conditions studied

  • Endometrial Cancer

Keywords

  • uterine cancer
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In context

Endometrial Neoplasms

1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.

This study's planned enrollment of 200 is above the median of 71 across 1,026 interventional studies indexed under Endometrial Neoplasms.

Browse Endometrial Neoplasms studies →

Lead sponsor

Barretos Cancer Hospital is the lead sponsor of 49 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Superficial cervical ICG injection

    Superficial cervical ICG injection for sentinel lymph node mapping

    Diagnostic Test: Superficial cervical ICG injection

  • Active comparator
    Deep and superficial ICG cervical injection

    Deep and superficial ICG cervical injection

    Diagnostic Test: Deep and superficial ICG cervical injection

Interventions

  • Diagnostic testSuperficial cervical ICG injection

    Superficial ICG cervical injections

    Also known as: Superficial cervical ICG injection for sentinel lymph node mapping

  • Diagnostic testDeep and superficial ICG cervical injection

    Deep and superficial ICG cervical injection for sentinel lymph node mapping

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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 12 weeks

  2. 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.

    Time frame: From enrollment to the end of treatment at 12 weeks

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Study locations

No study locations are listed for this record.

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References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Statistical analysis plan

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Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Dec 2026; primary completion for Aug 2030, 44 months later.

Of 195 non-industry interventional studies with no phase under Endometrial Neoplasms, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 76. This study's planned 44 months is close to that.

Counting every sponsor, half of 201 studies reached it within 43 months; a quarter within 19 and three quarters within 76.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2026
First posted
Nov 4, 2026
StartEst.
Dec 1, 2026
Primary completionEst.
Aug 2030
CompletionEst.
Dec 2030
Last update
Nov 4, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Nov 4, 2026
Show all 1 update
  1. Nov 4, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

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Registry details

Key details

Study ID
NCT07916610
Lead sponsor
Barretos Cancer Hospital
Responsible party
Ricardo dos Reis (Professor of Postgraduated Course, Barretos Cancer Hospital) — Principal investigator
First posted
Nov 4, 2026
Start date
Dec 1, 2026 (estimated)
Primary completion
Aug 2030 (estimated)
Completion
Dec 2030 (estimated)
Last update
Nov 4, 2026

Study contacts

Luis Pires Melo Filho, Dr
Contact
luisfilho4@hotmail.com
1733216600 ext. 7126

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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