Vulva CancerSENTIVUC IINCT06161428
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
An observational study of Vulva Cancer and Sentinel Lymph Node, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulva Cancer, Sentinel Lymph Node
- How many people
- 100 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2023to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with primary or recurrent vulva cancer
Who may be able to join
- Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Copenhagen University Hospital
Copenhagen, 2100
Ligita P Frøding, +4522722972, ligita.paskeviciute.froeding@regionh.dk
About this study
Official title: 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.
- Conditions
- Vulva Cancer, Sentinel Lymph Node
- Medical subject headings
- Vulvar Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity
Sensitivity of sentinel lymph node mapping
Measured: Three years
Secondary outcomes (1)
Negative predictive value
Negative predictive value of sentinel lymph node mapping
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2023
- Study start1 May 2023
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vulva CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital
- Responsible party
- Principal investigator, Ligita Paskeviciute Froding, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06161428
- Sponsor's protocol ID
- P-2022-946
- Acronym
- SENTIVUC II
- Status last verified
- Dec 2023
- First submitted
- 29 Nov 2023
- Last updated
- 13 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
- ClinicalTrials.gov ID
- NCT06161428
- Acronym / sponsor ID
- SENTIVUC II / P-2022-946
- Conditions
- Vulva Cancer, Sentinel Lymph Node
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aarhus University Hospital
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 7 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with primary or recurrent vulva cancer
Key inclusion criteria (1 listed)
- Patients with vulva cancer, tumor > 4 cm, multifocal tumor, or local recurrences in vulva
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity
Time frame: Three years
Sensitivity of sentinel lymph node mapping
1 secondary outcome
Negative predictive value
Time frame: Three years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulva Cancer and Sentinel Lymph Node, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ligita P Frøding (+4522722972, ligita.paskeviciute.froeding@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Three years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2023.