- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06161428
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (SENTIVUC II)
December 7, 2023 updated by: Ligita Paskeviciute Froding, Rigshospitalet, Denmark
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
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.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ligita P Frøding
- Phone Number: +4522722972
- Email: ligita.paskeviciute.froeding@regionh.dk
Study Locations
-
-
-
Copenhagen, Denmark, 2100
- Recruiting
- Copenhagen University Hospital
-
Contact:
- Ligita P Frøding
- Phone Number: +4522722972
- Email: ligita.paskeviciute.froeding@regionh.dk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Patients with primary or recurrent vulva cancer
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity
Time Frame: Three years
|
Sensitivity of sentinel lymph node mapping
|
Three years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Negative predictive value
Time Frame: Three years
|
Negative predictive value of sentinel lymph node mapping
|
Three years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2023
Primary Completion (Estimated)
July 1, 2026
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
November 29, 2023
First Submitted That Met QC Criteria
November 29, 2023
First Posted (Actual)
December 7, 2023
Study Record Updates
Last Update Posted (Actual)
December 13, 2023
Last Update Submitted That Met QC Criteria
December 7, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P-2022-946
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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