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

Launched by RIGSHOSPITALET, DENMARK · Sep 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a new method for staging vulvar cancer, which is a type of cancer that occurs in the external female genitalia. The researchers want to find out if a procedure called Sentinel Node biopsy can be done without a special imaging technique called lymphoscintigraphy, using a different dye called ICG instead. This trial will also explore how well combining PET-CT scans and ultrasound helps identify any spread of cancer to nearby lymph nodes in women who have a single tumor in the vulva that is less than 4 cm in size.

To participate in this trial, women aged 65 to 74 with primary vulvar cancer or a unifocal recurrence (meaning the cancer is in one spot) may be eligible, as long as their tumor is under 4 cm and they have not had prior surgery or radiation in the affected area. Participants can expect to undergo imaging tests and the biopsy procedure, and they will be closely monitored throughout the study. It's important to note that individuals who have allergies to ICG or iodine, or those who have had previous treatments in the relevant area, cannot join the trial. Overall, this research aims to improve the way vulvar cancer is diagnosed and treated.

Gender

FEMALE

Eligibility criteria

• 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)