Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06161428

Acronym

SENTIVUC II

Enrollment

100

Registered

2023-12-07

Start date

2023-05-01

Completion date

2027-07-01

Last updated

2023-12-13

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

Conditions

Sentinel Lymph Node, Vulva Cancer

Brief summary

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with vulva cancer tumour size \>4 cm, multifocal tumors and local recurrences.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with vulva cancer, tumor \> 4 cm, multifocal tumor, or local recurrences in vulva

Exclusion criteria

* Previous external irradiation of the vulva or groins * Former sentinel node or inguinal lymphadenectomy in the relevant groin * Known allergy to ICG or iodine * Patient is in active treatment for other cancer and/or disseminated disease

Design outcomes

Primary

Measure	Time frame	Description
Sensitivity	Three years	Sensitivity of sentinel lymph node mapping

Secondary

Measure	Time frame	Description
Negative predictive value	Three years	Negative predictive value of sentinel lymph node mapping

Countries

Denmark

Contacts

Primary ContactLigita P Frøding

ligita.paskeviciute.froeding@regionh.dk+4522722972

Outcome results