MRI and Magnetometer-guided Sentinel Lymph Node Detection in Vulvar Cancer

NAEnrolling by invitationINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

March 24, 2022

Primary Completion Date

December 1, 2024

Study Completion Date

December 31, 2024

Conditions
Vulvar CancerLymph Node Metastasis
Interventions
DRUG

Magtrace

Patients will receive superficial and interstitial injection with a 23 G needle with of a total volume of 0.1 - 1 ml Magtrace at four sites in or near the tumor in vulva, the same localization as the injections of Technetium99m and Patent blue for tracing SLNs performed at the surgery. The injection is performed by one of the gynecologic cancer surgeons participating in this study.The time of migration of SPIO to the groin nodes is not known for vulvar cancer. Transportation by dynamic MRI, with selective sequences repeated during a time span of 1- 60 minutes after the injection.

Trial Locations (1)

41345

Department of Obstetrics and gynecology, Gothenburg

All Listed Sponsors
lead

Sahlgrenska University Hospital

OTHER