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Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer (I) (SENTIVUC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06029504
Recruitment Status : Recruiting
First Posted : September 8, 2023
Last Update Posted : December 6, 2023
Sponsor:
Collaborator:
Aarhus University Hospital
Information provided by (Responsible Party):
Ligita Paskeviciute Froding, Rigshospitalet, Denmark

Study Description
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Brief Summary:
The aim of this study is to investigate whether Sentinel Node biopsy can be performed without the use of lymphoscintigraphy and with ICG as a mono-tracer in women with vulvar cancer, unifocal tumor < 4 cm (clinical stage IB and II). Further, to investigate the accuracy of combined PET-CT and ultrasound (US) of the groins with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in women with vulvar cancer, unifocal tumor < 4 cm.

Condition or disease
Vulvar Cancer Sentinel Lymph Node

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 115 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
Actual Study Start Date : January 1, 2023
Estimated Primary Completion Date : December 31, 2026
Estimated Study Completion Date : December 31, 2027

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Sentinel Node detection rate [ Time Frame: Three years ]
    SN detection rate with ICG and 99mTc-Nanocoll alone perioperatively, where lymphoscintigraphy is blinded, in patients with vulvar cancer (tumor < 4 cm) without clinical suspicion of metastases to the inguinal lymph nodes.


Secondary Outcome Measures :
  1. Sensitivity, specificity, PPV and NPV [ Time Frame: Three years ]
    Sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of FDG PET-CT and US combined with US-guided biopsy of suspicious lymph nodes for the identification of macro-metastases in the groins


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with primary or recurrent vulva cancer
Criteria

Inclusion Criteria:

  • Patients with primary vulva cancer, FIGO stage IB (tumor < 4 cm)
  • Patients with unifocal recurrence in the vulva (tumor < 4 cm) located on the side where the patient is surgically naïve in the groin

Exclusion Criteria:

  • Prior irradiation of the vulva or groins
  • Prior SNB or inguinal lymphadenectomy in the relevant groin
  • Known allergy to ICG or iodine (ICG contains 5% sodium iodine)
Contacts and Locations
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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): NCT06029504


Contacts
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Contact: Ligita P Frøding +4522722972 ligita.paskeviciute.froeding@regionh.dk

Locations
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Denmark
Copenhagen University Hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Ligita P Frøding    +4522722972    ligita.paskeviciute.froeding@regionh.dk   
Sponsors and Collaborators
Rigshospitalet, Denmark
Aarhus University Hospital
More Information
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Responsible Party: Ligita Paskeviciute Froding, Principal Investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT06029504    
Other Study ID Numbers: H-18020235
First Posted: September 8, 2023    Key Record Dates
Last Update Posted: December 6, 2023
Last Verified: September 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvar Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Vulvar Diseases
 Genital Diseases, Female
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Genital Diseases