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The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.
Full description
Vulvar carcinoma (VC) is a rare disease (4% of gynecological cancers) and the treatment is not yet universally defined. No official guidelines are currently available to define imaging techniques useful for staging. In the pre-operative evaluation of the pateints, imaging should assess nodal status; the available exams are:
The incidence of inguinal and pelvic lymph node metastasis not diagnosed at the pre-operative imaging is 10-35% as assessed after lymphadenectomy at pathology report.
Until 2009, the standard surgical treatment of vulvar cancer was represented by mono or bilateral systematic lymphadenectomy (at least 70% of N0 women underwent a radical surgery with the risk of severe morbidity related to the surgical procedure with no survival benefit).
Inguinal lymphadenectomy shows a high rate of local and systemic complications resulting in a longer hospitalization or recovery, as well as possible delays in adjuvant therapies.
Moreover, severe complications can lead to a further surgery.
Possibile complications described in literature are:
Since 2009, with the introduction and the validation of sentinel node biopsy (SNB), for some VC it is now possible to obtain a nodal staging with minimally invasive surgery and lower morbidity. However, the SNB technique is indicated if the tumor fits the following selection criteria:
Consequently in many tumors diagnosed as N0 at preoperative imaging, SNB technique is not indicated; these tumors still require systematic lymphadenectomy.
In this subset of patients it is important to identify new methods for preoperative evaluation of nodal status or to define a sub-category of patients for which the SNB could be applied.
Objective of the study is to verify, in patients actually off-label for SNB, the accuracy of 18FDG-PET/CT in predicting nodal status, as an indipendent method or associated with the standard pre-operative imaging and the mini-invasive surgical staging.
All patients are submitted to:
Vulvar surgery may include:
During inguinal surgery all patients will undergo:
Statistical analysis will help determine the accuracy and negative predictive value of FDG-PET/CT and sentinel node biopsy in predicting nodal status.
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Inclusion criteria
In addition, both major criteria and at least one of the minor criteria must be present:
MAJOR CRITERIA
MINOR CRITERIA
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50 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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