None listed
Conditions
Brief summary
Standard treatment of vulvar cancer includes surgery to remove the primary tumour, and if required, removal of groin lymph nodes. Groin Lymph Node Dissection (LND) can be delivered through a full inguinofemoral node dissection (removing as many nodes as possible) or through sentinel node biopsy (SNB -removing only one or two targeted groin lymph nodes). While the gold standard is often curative, groin LND is associated with debilitating long-term outcomes for virtually all women. The aim of this study is to assess the feasibility and accuracy of using high-resolution groin ultrasound as a non-invasive alternative method of identifying lymph node involvement in these patients. Who is it for? You may be eligible for this study if you are aged 18 years and over, have been diagnosed with vulvar cancer (i.e. without evidence of regional or distant metastatic disease), and are scheduled to undergo surgery to the vulva and groin(s) within the next 30 days. Study details 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 measurements of any identified lymph nodes, and will take between 30 and 45 minutes to complete. After their planned surgery, any removed lymph nodes will be assessed by a pathologist for detection of spread of vulvar cancer cells. This will then be compared to the ultrasound measurements to determine whether groin ultrasound can be used to predict nodal involvement. 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.
Interventions
Groin ultrasound to assess groin lymph node involvement in patients with histologically proven vulvar cancer.
Eligible participants will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery. The groin ultrasound will capture 6 variables of interest for each identified groin node on a study specific case report form: shape (globular vs non globular); homogeneity of echo structure; hyper- or hypoechoic areas within the lymph nodes; hilum abnormalities; cortical thicke
Groin ultrasound to assess groin lymph node involvement in patients with histologically proven vulvar cancer. Eligible participants will receive a bilateral groin node ultrasound up to 30 days prior to planned surgery. The groin ultrasound will capture 6 variables of interest for each identified groin node on a study specific case report form: shape (globular vs non globular); homogeneity of echo structure; hyper- or hypoechoic areas within the lymph nodes; hilum abnormalities; cortical thickening; and nodal grouping For the most suspicious or largest lymph node: long (L) and short (S) axis; L/S ratio (values of <2 are considered abnormal); cortical (C) and medullar (M) thickness; C/M ratio (values >1 are considered abnormal); perinodal hyperechoic ring (inflammation); cortical interruption (possibility of extra-nodal spread); nodal vascularity. An overall assessment will be made by the radiologist into normal, indeterminate or suspicious/positive. All groin ultrasound examinations will be performed by registered sonographers recognised by the Australian Sonographers Accreditation Registry. No preparation is required for a groin ultrasound. Examinations usually take between 30 and 45 minutes and participants will be given instructions on how to prepare for their ultrasound examinations and what happens during the procedure and the sonographer will guide them throughout the procedure. Participants will undergo a bilateral groin high-resolution ultrasound examination once only. A Central Review of all ultrasound images will be used to ensure optimal quality and to monitor adherence to the intervention.
Sponsors
University of Queensland
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Females, over 18 years, with histologically confirmed squamous cell carcinoma (SCC), adenocarcinoma or melanoma of the vulva - Undergo inguino-femoral lymphadenectomy /sentinel node biopsy according to local clinical practice management guidelines - Signed written informed consent - Negative serum pregnancy test less than or equal to 30 days of surgery in pre-menopausal women and women < 2 years after the onset of menopause.
Exclusion criteria
- Women with non-invasive vulvar conditions (e.g. non-invasive non-mammary Paget’s disease) - SCC of the vulva with depth of invasion less than or equal to 1 mm - Clinical or medical imaging evidence of regional and/or distant metastatic disease - Serious concomitant systemic disorders incompatible with the study (at the discretion of the investigator) - Other prior malignancies <5 years before inclusion, except for successfully treated keratinocyte skin cancers, or ductal carcinoma in situ.
Outcome results
None listed