<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02969278</url>
  </required_header>
  <id_info>
    <org_study_id>GroSNaPET</org_study_id>
    <nct_id>NCT02969278</nct_id>
  </id_info>
  <brief_title>Groin Sentinel Node Biopsy and 18FDG-PET/CT in cN0 Vulvar Cancer Patients Candidate to Standard Lymphadenectomy</brief_title>
  <acronym>GroSNaPET</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Catholic University of the Sacred Heart</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Catholic University of the Sacred Heart</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aim is to verify the accuracy of SNB combined with 18F-FDG PET/CT in cN0 invasive&#xD;
      vulvar cancer (IVC) patients currently not candidate to SNB according to standard guidelines.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Vulvar carcinoma (VC) is a rare disease (4% of gynecological cancers) and the treatment is&#xD;
      not yet universally defined. No official guidelines are currently available to define imaging&#xD;
      techniques useful for staging. In the pre-operative evaluation of the pateints, imaging&#xD;
      should assess nodal status; the available exams are:&#xD;
&#xD;
        -  CT or MRI with contrast (abdominal and pelvic with caudal scans for inguinal regions)&#xD;
&#xD;
        -  Inguinal ultrasound with US-guided biopsy/fine needle aspiration for suspicious lymph&#xD;
           nodes.&#xD;
&#xD;
      The incidence of inguinal and pelvic lymph node metastasis not diagnosed at the pre-operative&#xD;
      imaging is 10-35% as assessed after lymphadenectomy at pathology report.&#xD;
&#xD;
      Until 2009, the standard surgical treatment of vulvar cancer was represented by mono or&#xD;
      bilateral systematic lymphadenectomy (at least 70% of N0 women underwent a radical surgery&#xD;
      with the risk of severe morbidity related to the surgical procedure with no survival&#xD;
      benefit).&#xD;
&#xD;
      Inguinal lymphadenectomy shows a high rate of local and systemic complications resulting in a&#xD;
      longer hospitalization or recovery, as well as possible delays in adjuvant therapies.&#xD;
&#xD;
      Moreover, severe complications can lead to a further surgery.&#xD;
&#xD;
      Possibile complications described in literature are:&#xD;
&#xD;
        -  Lymphedema (up to 70%)&#xD;
&#xD;
        -  Infection and postoperative cellulitis (50%)&#xD;
&#xD;
        -  Inguinal suture dehiscence (between 22 and 52%)&#xD;
&#xD;
        -  Linfocysts (between 7 and 28%)&#xD;
&#xD;
        -  Deep vein thrombosis (between 5 and 8%)&#xD;
&#xD;
        -  Sepsis (1 -2%)&#xD;
&#xD;
      Since 2009, with the introduction and the validation of sentinel node biopsy (SNB), for some&#xD;
      VC it is now possible to obtain a nodal staging with minimally invasive surgery and lower&#xD;
      morbidity. However, the SNB technique is indicated if the tumor fits the following selection&#xD;
      criteria:&#xD;
&#xD;
        -  Infiltrating tumors with a diameter &lt; 40 mm;&#xD;
&#xD;
        -  Monofocal tumors;&#xD;
&#xD;
        -  Tumors distant more than 1 cm from the midline&#xD;
&#xD;
        -  Tumors near the midline with bilateral lymphatic drainage and intraoperative detection&#xD;
           of at least one sentinel node for each groin.&#xD;
&#xD;
      Consequently in many tumors diagnosed as N0 at preoperative imaging, SNB technique is not&#xD;
      indicated; these tumors still require systematic lymphadenectomy.&#xD;
&#xD;
      In this subset of patients it is important to identify new methods for preoperative&#xD;
      evaluation of nodal status or to define a sub-category of patients for which the SNB could be&#xD;
      applied.&#xD;
&#xD;
      Objective of the study is to verify, in patients actually off-label for SNB, the accuracy of&#xD;
      18FDG-PET/CT in predicting nodal status, as an indipendent method or associated with the&#xD;
      standard pre-operative imaging and the mini-invasive surgical staging.&#xD;
&#xD;
      All patients are submitted to:&#xD;
&#xD;
        -  Gynecologic visit&#xD;
&#xD;
        -  Vulvar biopsy and possible pelvic examination under anesthesia with the definition of&#xD;
           clinical extent of disease&#xD;
&#xD;
        -  Evaluation of serum tumor markers: SCC and Ca125&#xD;
&#xD;
        -  Inguinal ultrasound and possible US guided FNAC or FNAB on suspicious lymph nodes&#xD;
&#xD;
        -  CT scan (abdomen and pelvis) with contrast&#xD;
&#xD;
        -  18FDG-PET/CT&#xD;
&#xD;
        -  Lymphangioscintigraphy of inguinofemoral axis&#xD;
&#xD;
      Vulvar surgery may include:&#xD;
&#xD;
        -  Wide resection of vulvar disease&#xD;
&#xD;
        -  Emivulvectomy (anterior, posterior or lateral)&#xD;
&#xD;
        -  Simple vulvectomy&#xD;
&#xD;
        -  Radical or ultra-radical vulvectomy (with possible plastic reconstruction)&#xD;
&#xD;
      During inguinal surgery all patients will undergo:&#xD;
&#xD;
      - Sentinel node biopsy mono or bilateral followed by radical bilateral inguinal&#xD;
      lymphadenectomy&#xD;
&#xD;
      Statistical analysis will help determine the accuracy and negative predictive value of&#xD;
      FDG-PET/CT and sentinel node biopsy in predicting nodal status.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications</measure>
    <time_frame>within the first 30 days after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy and Negative Predictive Value of preoperative 18F FDG-PET/CT for the selection of cN0 patients.</measure>
    <time_frame>within the first 60 days before surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Vulvar Cancer</condition>
  <arm_group>
    <arm_group_label>Vulvar cancer patients cN0 unfit for sentinel node biopsy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All invasive vulvar cancer patients with cN0 status:&#xD;
T &gt; 4 cm;&#xD;
multicentric tumors (mono or bilateral);&#xD;
primary lesion completely excised during prior diagnostic surgery&#xD;
patients candidate to bilateral lymphadenectomy because of unilateral groin lymph node involvement, contralateral cN0&#xD;
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</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>18FDG-PET/TC</intervention_name>
    <description>Nuclear medicine exam (18FDG-PET/TC) to assess the status of the regional groin and pelvic lymphnodes</description>
    <arm_group_label>Vulvar cancer patients cN0 unfit for sentinel node biopsy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sentinel node biopsy</intervention_name>
    <description>Intradermal injection of 0.2 ml 37-148 MBq of radiocolloid and a blue dye near the tumor to locate the position of the sentinel lymph node. Intraoperatively, sentinel node localization is guided by a gamma probe and by the eyes of the surgeon who detects the lymph nodes that are stained with the blue dye.</description>
    <arm_group_label>Vulvar cancer patients cN0 unfit for sentinel node biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age&gt; 18 years&#xD;
&#xD;
          -  ECOG ≤ 2&#xD;
&#xD;
          -  Adequate respiratory, hepatic, cardiac, bone marrow and renal function (creatinine&#xD;
             clearance&gt; 60 mL/min according to the Cockroft formula)&#xD;
&#xD;
          -  Patient psychologically able to follow the study procedures&#xD;
&#xD;
          -  Signature of informed consent&#xD;
&#xD;
        In addition, both major criteria and at least one of the minor criteria must be present:&#xD;
&#xD;
        MAJOR CRITERIA&#xD;
&#xD;
          -  Vulvar carcinoma (stromal infiltration &gt; 1 mm); Histotypes different from squamous are&#xD;
             included&#xD;
&#xD;
          -  Negative lymphnodes at preoperative imaging&#xD;
&#xD;
        MINOR CRITERIA&#xD;
&#xD;
          -  Vulvar lesion greater than 4 cm&#xD;
&#xD;
          -  Multifocal or bilateral lesions&#xD;
&#xD;
          -  Previous complete excisional biopsy of the vulvar lesion, with absent residual disease&#xD;
&#xD;
          -  Previous neoadjuvant treatment (radiotherapy a/o sequential/concomitant chemotherapy)&#xD;
&#xD;
          -  Previous treatment with radiotherapy a/o chemotherapy (sequential a/o concomitant) for&#xD;
             previous vulvar cancer a/o other diseases&#xD;
&#xD;
          -  Previous vulvar or inguinal surgery&#xD;
&#xD;
          -  Infiltrating vulvar carcinoma with monolateral groin lymphnode involvement (N1) and&#xD;
             contralateral N0&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to egg proteins and albumin&#xD;
&#xD;
          -  Pregnancy and breastfeeding&#xD;
&#xD;
          -  Patients with impaired respiratory, hepatic, cardiac, bone marrow and renal function&#xD;
             (creatinine clearance&gt; 60 mL / min according to the Cockroft formula)&#xD;
&#xD;
          -  Patients with major depressive disorder&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Division of Gynecologic Oncology/Fondazione Policlinico Gemelli</name>
      <address>
        <city>Rome</city>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Giorgia Garganese, MD</last_name>
      <phone>00390630158545</phone>
      <email>ggarganese@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Simona M Fragomeni, MD</last_name>
      <phone>00390630158545</phone>
      <email>simona.fragomeni@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Giovanni Scambia, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Alessandro Giordano, Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Vittoria Rufini, Professor</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Giorgia Garganese, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Simona M Fragomeni, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 17, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>November 17, 2016</last_update_submitted>
  <last_update_submitted_qc>November 17, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Catholic University of the Sacred Heart</investigator_affiliation>
    <investigator_full_name>Prof. Giovanni Scambia</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>vulvar cancer</keyword>
  <keyword>sentinel node biopsy</keyword>
  <keyword>inguino-femoral lymphadenectomy</keyword>
  <keyword>18F FDG- PET/TC</keyword>
  <keyword>guidelines</keyword>
  <keyword>preoperative imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvar Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02969278
org study id: GroSNaPET
nct id: NCT02969278
lead sponsor: 
has dmc: No
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.
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
           nodes.

      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:

        -  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
      criteria:

        -  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
      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:

        -  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
      lymphadenectomy

      Statistical analysis will help determine the accuracy and negative predictive value of
      FDG-PET/CT and sentinel node biopsy in predicting nodal status.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Accuracy and Negative Predictive Value of sentinel node biopsy in cN0 vulvar cancer patients that do not fit for the current indications
time frame: within the first 30 days after surgery
measure: Accuracy and Negative Predictive Value of preoperative 18F FDG-PET/CT for the selection of cN0 patients.
time frame: within the first 60 days before surgery
arm group label: Vulvar cancer patients cN0 unfit for sentinel node biopsy
arm group type: Experimental
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
intervention type: Procedure
intervention name: 18FDG-PET/TC
description: Nuclear medicine exam (18FDG-PET/TC) to assess the status of the regional groin and pelvic lymphnodes
arm group label: Vulvar cancer patients cN0 unfit for sentinel node biopsy
intervention type: Procedure
intervention name: Sentinel node biopsy
description: Intradermal injection of 0.2 ml 37-148 MBq of radiocolloid and a blue dye near the tumor to locate the position of the sentinel lymph node. Intraoperatively, sentinel node localization is guided by a gamma probe and by the eyes of the surgeon who detects the lymph nodes that are stained with the blue dye.
arm group label: Vulvar cancer patients cN0 unfit for sentinel node biopsy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
investigator: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Catholic University of the Sacred Heart
investigator full name: Prof. Giovanni Scambia
investigator title: Professor
mesh term: Vulvar Neoplasms
mesh term: Fluorodeoxyglucose F18
sharing ipd: No