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
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Condition or disease |
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Vulvar Cancer Sentinel Lymph Node |
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 |
- 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.
- 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
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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 |
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)
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
Contact: Ligita P Frøding | +4522722972 | ligita.paskeviciute.froeding@regionh.dk |
Denmark | |
Copenhagen University Hospital | Recruiting |
Copenhagen, Denmark, 2100 | |
Contact: Ligita P Frøding +4522722972 ligita.paskeviciute.froeding@regionh.dk |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |