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Evaluation of near-infrared fluorescence (NIRF) imaging for sentinel lymph node (SLN) detection in squamous cell carcinoma of the vulva: a feasibility study

Evaluation of near-infrared fluorescence (NIRF) imaging for sentinel lymph node (SLN) detection in squamous cell carcinoma of the vulva: a feasibility study - Sentinel node detection in vulvar cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33082
Enrollment
10
Registered
2009-06-12
Start date
2009-06-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

sentinel lymph node vulvar carcinoma

Interventions

Injection of ICG together with patent blue (golden standard)

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: female > 21 yrs of age with biopsy proven squamous cell carcinoma of the vulva who are eligible for a sentinel node procedure

Exclusion criteria

Exclusion criteria: Pregnant women, significant renal (creatinine > 110 ug/l), cardiac, or pulmonary disease (ASA III-IV), History of iodine allergy or anaphylactic reactions to insect bites or medication, presence or history of hyperthyroidism.

Design outcomes

Primary

MeasureTime frame
the number and localisation of sentinel lymph node(s) detected with the camera and ICG, compared to the detection with radiocolloid and patent blue

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)