Summary
Standard treatment for vulvar cancer usually involves surgery to remove the tumour, and if required,the lymph nodes in the groin. This can be done by removing as many nodes as possible (called a full inguinofemoral node dissection) or just a few targeted ones (called a sentinel node biopsy).
While these procedures are often effective at treating the cancer, they can lead to long-term side effects for many women. This study is exploring whether a high-resolution groin ultrasound can be a safe and accurate way to check for cancer spread to the lymph nodes.
You may be eligible for this study if you are aged 18 years or over, have been diagnosed with vulvar cancer (without evidence of regional or distant metastatic disease), and are scheduled to undergo surgery to the vulva and groin within the next 30 days.
Up to 30 days prior to their planned surgery, all participants will undergo a bilateral (i.e. on both sides) groin ultrasound. This will involve a radiologist placing a small probe on the groin to take measures of any identified lymph nodes, and will take between 30-45 minutes to complete.
After their planned surgery, any removed lymph nodes will be assessed by a pathologist. These results will be compared to the ultrasound findings to see how well the scan predicts cancer involvement in the lymph nodes.
It is hoped that this study may show that non-invasive groin ultrasound is a feasible and accurate method of predicting nodal involvement in vulvar cancer patients. If so, the ability to predict the absence of nodal involvement may spare future vulvar cancer patients unnecessary LND procedures to reduce complications, improve recovery time, and facilitate their return to normal daily activities.
Conditions
This trial is treating people with volvar cancer who are scheduled to undergo surgery to remove the cancer and, if necessary, lymph nodes