Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy

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Brief Title

Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy

Official Title

Study on the Prediction of Groin Lymphonodal Status Through 18FDG-PET/CT Combined With Sentinel Lymph Node Biopsy in Bulky a/o Multifocal a/o Pretreated Vulvar Cancer, N0 at Conventional Imaging (GRO-SNaPET Study)

Brief Summary

      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.

Detailed 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:

        -  CT or MRI with contrast (abdominal and pelvic with caudal scans for inguinal regions)

        -  Inguinal ultrasound with US-guided biopsy/fine needle aspiration for suspicious lymph

      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

      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:

        -  Lymphedema (up to 70%)

        -  Infection and postoperative cellulitis (50%)

        -  Inguinal suture dehiscence (between 22 and 52%)

        -  Linfocysts (between 7 and 28%)

        -  Deep vein thrombosis (between 5 and 8%)

        -  Sepsis (1 -2%)

      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

        -  Infiltrating tumors with a diameter < 40 mm;

        -  Monofocal tumors;

        -  Tumors distant more than 1 cm from the midline

        -  Tumors near the midline with bilateral lymphatic drainage and intraoperative detection
           of at least one sentinel node for each groin.

      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

      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:

        -  Gynecologic visit

        -  Vulvar biopsy and possible pelvic examination under anesthesia with the definition of
           clinical extent of disease

        -  Evaluation of serum tumor markers: SCC and Ca125

        -  Inguinal ultrasound and possible US guided FNAC or FNAB on suspicious lymph nodes

        -  CT scan (abdomen and pelvis) with contrast

        -  18FDG-PET/CT

        -  Lymphangioscintigraphy of inguinofemoral axis

      Vulvar surgery may include:

        -  Wide resection of vulvar disease

        -  Emivulvectomy (anterior, posterior or lateral)

        -  Simple vulvectomy

        -  Radical or ultra-radical vulvectomy (with possible plastic reconstruction)

      During inguinal surgery all patients will undergo:

      - Sentinel node biopsy mono or bilateral followed by radical bilateral inguinal

      Statistical analysis will help determine the accuracy and negative predictive value of
      FDG-PET/CT and sentinel node biopsy in predicting nodal status.

Study Type


Primary Outcome

Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications

Secondary Outcome

 Accuracy and Negative Predictive Value of preoperative 18F FDG-PET/CT for the selection of cN0 patients.


Vulvar Cancer



Study Arms / Comparison Groups

 Vulvar cancer patients cN0 unfit for sentinel node biopsy
Description:  All invasive vulvar cancer patients with cN0 status:
T > 4 cm;
multicentric tumors (mono or bilateral);
primary lesion completely excised during prior diagnostic surgery
patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0
previous radiotherapy a/o chemotherapy (sequential or concurrent). These patients are submitted to 18FDG PET/TC and sentinel node biopsy associated with standard preoperative imaging and radical groin lymphadenectomy


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status


Estimated Enrollment


Start Date

July 2013

Completion Date

July 2017

Primary Completion Date

July 2017

Eligibility Criteria

        Inclusion Criteria:

          -  Age> 18 years

          -  ECOG ≤ 2

          -  Adequate respiratory, hepatic, cardiac, bone marrow and renal function (creatinine
             clearance> 60 mL/min according to the Cockroft formula)

          -  Patient psychologically able to follow the study procedures

          -  Signature of informed consent

        In addition, both major criteria and at least one of the minor criteria must be present:


          -  Vulvar carcinoma (stromal infiltration > 1 mm); Histotypes different from squamous are

          -  Negative lymphnodes at preoperative imaging


          -  Vulvar lesion greater than 4 cm

          -  Multifocal or bilateral lesions

          -  Previous complete excisional biopsy of the vulvar lesion, with absent residual disease

          -  Previous neoadjuvant treatment (radiotherapy a/o sequential/concomitant chemotherapy)

          -  Previous treatment with radiotherapy a/o chemotherapy (sequential a/o concomitant) for
             previous vulvar cancer a/o other diseases

          -  Previous vulvar or inguinal surgery

          -  Infiltrating vulvar carcinoma with monolateral groin lymphnode involvement (N1) and
             contralateral N0

        Exclusion Criteria:

          -  Allergy to egg proteins and albumin

          -  Pregnancy and breastfeeding

          -  Patients with impaired respiratory, hepatic, cardiac, bone marrow and renal function
             (creatinine clearance> 60 mL / min according to the Cockroft formula)

          -  Patients with major depressive disorder




18 Years - N/A

Accepts Healthy Volunteers



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Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Catholic University of the Sacred Heart

Study Sponsor

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Verification Date

November 2016