Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I)

Vulvar Cancer Clinical Trial

— SENTIVUC  

Official title:

Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029504
• Other study ID #: H-18020235
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: September 2023
• Source: Rigshospitalet, Denmark
• Contact: Ligita P Frøding
• Phone: +4522722972
• Email: ligita.paskeviciute.froeding[@]regionh.dk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor < 4 cm.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 115
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with primary vulva cancer, FIGO stage IB (tumor < 4 cm)

• Patients with unifocal recurrence in the vulva (tumor < 4 cm) located on the side where the patient is surgically naïve in the groin

Exclusion Criteria:

• Prior irradiation of the vulva or groins

• Prior SNB or inguinal lymphadenectomy in the relevant groin

• Known allergy to ICG or iodine (ICG contains 5% sodium iodine)

Related Conditions & MeSH terms

• Sentinel Lymph Node
• Vulvar Cancer
• Vulvar Neoplasms

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sentinel Node detection rate	SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor < 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.	Three years
Secondary	Sensitivity, specificity, PPV and NPV	Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins	Three years