NCT06161428

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
14mo left

Started May 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
May 2023Jul 2027

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 7, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2027

Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

3.2 years

First QC Date

November 29, 2023

Last Update Submit

December 7, 2023

Conditions

Vulva CancerSentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

  • Sensitivity

    Sensitivity of sentinel lymph node mapping

    Three years

Secondary Outcomes (1)

  • Negative predictive value

    Three years

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with primary or recurrent vulva cancer

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Ligita P Frøding

CONTACT

+4522722972ligita.paskeviciute.froeding@regionh.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 29, 2023

First Posted

December 7, 2023

Study Start

May 1, 2023

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2027

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

DK(1)