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

NCT02969278 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2016-11-21

No results posted yet for this study

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.

Conditions

  • Vulvar Cancer

Interventions

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.

Sponsors & Collaborators

  • Catholic University of the Sacred Heart

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02969278 on ClinicalTrials.gov