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

Launched by SAHLGRENSKA UNIVERSITY HOSPITAL · Feb 15, 2024

Keywords

ClinConnect Summary

The POSVUC pilot trial is testing a new way to find sentinel lymph nodes (the first lymph nodes that drain a cancer) in vulvar cancer. Researchers want to know if using a magnetic iron oxide tracer (SPIO) with MRI before surgery and a magnetometer during surgery can identify these nodes as well as the current standard method (Technetium-based imaging and blue dye). It is a small feasibility study planned for about 20 adult women with vulvar cancer tumors smaller than 4 cm who are scheduled to have a sentinel lymph node biopsy. The study also looks at whether SPIO-MRI findings can predict whether the lymph nodes actually have cancer, comparing it to the final pathology results.

If you are invited to participate, you would receive SPIO injections near the tumor, followed by a preoperative MRI to map the tracer. During surgery, a magnetometer would help locate the sentinel lymph nodes. The study compares the new SPIO/MRI approach to the standard Tc-99m/dye method and, secondarily, tests whether MRI findings can predict nodal cancer. Eligible participants are female, 18 years or older, with a confirmed vulvar cancer less than 4 cm, and good performance status (ECOG 0-2); there must be no MRI safety issues or iron-related problems. The trial is being conducted at Sahlgrenska University Hospital in Gothenburg, Sweden, led by Principal Investigator Katja Stenström Bohlin, and is not a drug trial. Results will help determine if this approach could be used more broadly in the future.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Histologically confirmed primary VSCC \<4 cm, candidates for surgery with SLNB Age above 18
• • Signed and dated written consent before the start of specific protocol procedures.
• • ECOG performance status 0-2
• Exclusion Criteria:
• • Contraindications for MRI such as electronic implants or severe claustrophobia
• • Hip replacement
• • Iron overload disease 4. Known hypersensitivity to iron or dextran compounds
• • Inability to understand given information and give informed consent or undergo study procedure