Clinical trial · Observational
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study
NCT06039111CI-TRIAL-00107898IGNITE-VrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel lymph node detection in early stage vulvar cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG alone | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Sequential ICG and Technetium Detection
- description
- ICG alone for the detection of SLN in early vulvar cancer
- interventionNames
- Procedure: ICG alone
Primary outcomes (1)
- measure
- false-negative rate of the detection technique using ICG alone compared to ICG and Technetium (Dual method) per groin
- timeFrame
- 2 years
- description
- This will be calculated as the number of groins for which positive SLN were missed using ICG alone; i.e. the number of groins for which ICG did not detect a positive SLN but was detected by ICG and Technetium, divided by the number of groins for which surgery was performed.
Secondary outcomes (1)
- measure
- 1. The proportion of positive SLN detected by ICG for each groin divided by the total number of positive SLN detected using ICG and Technetium.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm). Exclusion Criteria: Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.
References
Publications (0)
Data not yet available
No reference posted for this study.