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Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

NCT ID: NCT06161428

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-05-01

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Vulva Cancer Sentinel Lymph Node

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Ligita Paskeviciute Froding

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Copenhagen University Hospital

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Ligita P Frøding

Role: CONTACT

Phone: +4522722972

Email: [email protected]

Facility Contacts

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Ligita P Frøding

Role: primary

Other Identifiers

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P-2022-946

Identifier Type: -

Identifier Source: org_study_id