Sentinel lymph node detection in vulvar cancer.

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON28244

Enrollment

Registered

2009-08-31

Start date

2009-07-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

vulvar cancer vulvacarcinoom

Interventions

Patients with unifocal squamous cell carcinoma of the vulva stage I or II, smaller than 4 cm undergoing surgery, combined with a sentinel lymph node procedure, will receive an peritumoural injection

Eligibility

Inclusion criteria

Inclusion criteria: 1. Female > 21 years of age; 2. Unifocal squamous cell carcinoma of the vulva proven by histology on a biopsy, depth of invasion > 1mm, tumour size < 4mm, no suspicious inguinal nodes on CT scan or palpation.

Exclusion criteria

Exclusion criteria: 1. Pregnancy; 2. Renal, cardiac or pulmonary failure (ASA III-IV); 3. Previous or present hyperthyreoidism; 4. Iodine allergy or previoius anaphylactic reactions.

Design outcomes

Primary

Measure	Time frame
Identification of sentinel lymph nodes within the allocated procedure (usually 15-30 minutes).	—

Contacts

Public ContactG.M. Dam, van

University Medical Center Groningen Department of Surgery / BioOptical Imaging Center Groningen

g.m.van.dam@chir.umcg.nl+31 (0)50 3612283

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)