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| Name | Class |
|---|---|
| Aarhus University Hospital | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
Exclusion Criteria:
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Patients with primary or recurrent vulva cancer
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ligita P Frøding | Contact | +4522722972 | ligita.paskeviciute.froeding@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D014845 |
| Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |