Sentinel Node Extended in Squamous Cell Vulvar Cancer

NCT04147780 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2023-11-01

No results posted yet for this study

Summary

The aim of this study is to investigate the feasibility of sentinel node biopsy in patients with squamous cell vulvar cancer, currently not regarded suitable for the sentinel node technique, i.e. patients with tumors ≥4cm, multifocal tumors or locally recurrent disease. A positive result of this pilot study might constitute the basis for a future full-scale multinational trial.

Conditions

  • Vulva Cancer
  • Sentinel Lymph Node

Interventions

PROCEDURE

Sentinel node biopsy

Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.

Sponsors & Collaborators

  • Sahlgrenska University Hospital

    collaborator OTHER
  • University Hospital, Linkoeping

    collaborator OTHER
  • Skane University Hospital

    collaborator OTHER
  • Diana Zach

    lead OTHER

Principal Investigators

  • Diana Zach, MD · Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-14
Primary Completion
2022-12-14
Completion
2023-02-15

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04147780 on ClinicalTrials.gov