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

NCT06029504 | Recruiting

• 1 other identifier: H-18020235
• Study Type: observational
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Vulvar Cancer; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity, specificity, PPV and NPV

  Three years

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with primary or recurrent vulva cancer

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rigshospitalet, Denmark: lead
• Aarhus University Hospital: collaborator

Study Sites (1)

Copenhagen University Hospital

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Ligita P Frøding

CONTACT

+4522722972; ligita.paskeviciute.froeding@regionh.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 1, 2023
• First Posted: September 8, 2023
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 6, 2023

Record last verified: 2023-09

Locations

DK (1)