Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-24 @ 5:26 PM
NCT ID:
NCT06035068
Eligibility Criteria:
Inclusion Criteria:
* 18 years of age or older
* Patients with early-stage SCC (diameter \<4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
* Patients with squamous cell carcinoma, depth of invasion \> 1mm
* Patients with T1 or T2 tumors (FIGO staging) \< 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
* Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
* Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes
* Willing and able to give informed consent
Exclusion Criteria:
* Inoperable tumors and tumors with diameter \> 4 cm
* Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
* Radiologically enlarged (\>1.5 cm) inguinofemoral lymph nodes
* Patients with multifocal tumors
* Pregnancy
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT06035068
Study Brief:
Protocol Section:
NCT06035068