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

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ClinicalTrials.gov Identifier: NCT02969278
Recruitment Status : Unknown
Verified November 2016 by Prof. Giovanni Scambia, Catholic University of the Sacred Heart.
Recruitment status was:  Recruiting
First Posted : November 21, 2016
Last Update Posted : November 21, 2016
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

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.

Condition or disease Intervention/treatment Phase
Vulvar Cancer Procedure: 18FDG-PET/TC Procedure: Sentinel node biopsy Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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)
Study Start Date : July 2013
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Vulvar cancer patients cN0 unfit for sentinel node biopsy

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
Procedure: 18FDG-PET/TC
Nuclear medicine exam (18FDG-PET/TC) to assess the status of the regional groin and pelvic lymphnodes

Procedure: Sentinel node biopsy
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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

MAJOR CRITERIA

  • Vulvar carcinoma (stromal infiltration > 1 mm); Histotypes different from squamous are included
  • Negative lymphnodes at preoperative imaging

MINOR CRITERIA

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02969278


Locations
Italy
Division of Gynecologic Oncology/Fondazione Policlinico Gemelli Recruiting
Rome, Italy, 00168
Contact: Giorgia Garganese, MD    00390630158545    ggarganese@gmail.com   
Contact: Simona M Fragomeni, MD    00390630158545    simona.fragomeni@gmail.com   
Principal Investigator: Giovanni Scambia, Professor         
Principal Investigator: Alessandro Giordano, Professor         
Sub-Investigator: Vittoria Rufini, Professor         
Sub-Investigator: Giorgia Garganese, MD         
Sub-Investigator: Simona M Fragomeni, MD         
Sponsors and Collaborators
Catholic University of the Sacred Heart

Responsible Party: Prof. Giovanni Scambia, Professor, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT02969278     History of Changes
Other Study ID Numbers: GroSNaPET
First Posted: November 21, 2016    Key Record Dates
Last Update Posted: November 21, 2016
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
vulvar cancer
sentinel node biopsy
inguino-femoral lymphadenectomy
18F FDG- PET/TC
guidelines
preoperative imaging

Additional relevant MeSH terms:
Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
Genital Diseases, Female
Fluorodeoxyglucose F18
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action