NCT02969278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

November 17, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

November 21, 2016

Status Verified

November 1, 2016

Enrollment Period

4 years

First QC Date

November 17, 2016

Last Update Submit

November 17, 2016

Conditions

Vulvar Cancer

Keywords

vulvar cancersentinel node biopsyinguino-femoral lymphadenectomy18F FDG- PET/TCguidelinespreoperative imaging

Outcome Measures

Primary Outcomes (1)

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

    within the first 30 days after surgery

Secondary Outcomes (1)

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

    within the first 60 days before surgery

Study Arms (1)

Vulvar cancer patients cN0 unfit for sentinel node biopsy

EXPERIMENTAL

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/TCProcedure: Sentinel node biopsy

Interventions

18FDG-PET/TCPROCEDURE

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

Vulvar cancer patients cN0 unfit for sentinel node biopsy
Sentinel node biopsyPROCEDURE

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.

Vulvar cancer patients cN0 unfit for sentinel node biopsy

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • +2 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Gynecologic Oncology/Fondazione Policlinico Gemelli

Rome, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Vulvar Neoplasms

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Intervention Hierarchy (Ancestors)

BiopsyCytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeLymph Node ExcisionInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 17, 2016

First Posted

November 21, 2016

Study Start

July 1, 2013

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

November 21, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)