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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06029504
Other study ID # H-18020235
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2027

Study information

Verified date September 2023
Source Rigshospitalet, Denmark
Contact Ligita P Frøding
Phone +4522722972
Email ligita.paskeviciute.froeding@regionh.dk
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 115
Est. completion date December 31, 2027
Est. primary completion date December 31, 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Denmark Copenhagen University Hospital Copenhagen

Sponsors (2)

Lead Sponsor Collaborator
Rigshospitalet, Denmark Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sentinel Node detection rate 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. Three years
Secondary Sensitivity, specificity, PPV and NPV 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 Three years
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