Optical Guided Sentinel Node Biopsy for Staging of Vulvar... | NCT06161428

Studies
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

NCT06161428

Sponsor

Rigshospitalet, Denmark

Status

Recruiting

Last Update Posted

Dec 13, 2023Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Vulva Cancer
Sentinel Lymph Node

Interventions

Not provided

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 1, 2023Actual

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Jul 1, 2027Estimated

First Submitted Date

Nov 29, 2023

First Submission Date that Met QC Criteria

Nov 29, 2023

First Posted Date

Dec 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 7, 2023

Last Update Posted Date

Dec 13, 2023Actual

Name	Class
Aarhus University Hospital	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with primary or recurrent vulva cancer

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ligita P Frøding	Contact	+4522722972		ligita.paskeviciute.froeding@regionh.dk

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Copenhagen University Hospital	Recruiting	Copenhagen		2100	Denmark

Condition Browse Module

MeSH Terms

ID	Term
D014846	Vulvar Neoplasms

Ancestor Terms

ID	Term
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Browse Leaves

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Browse Branches

Not provided