NCT05108090 Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
| NCT ID | NCT05108090 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 94 participants |
| Start Date | 2021-10-25 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 94 participants in total. It began in 2021-10-25 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to research if a type of biopsy known as sentinel lymph node biopsy (SLNB) can help in determining the rate of tumor deposits that are hard to detect and identify in node-negative cutaneous squamous cell carcinoma of the head or neck.
Eligibility Criteria
Inclusion Criteria: * Patients ≥ 18 years old at the time of informed consent * Ability to provide written informed consent and HIPAA authorization * Primary or recurrent invasive cutaneous squamous cell carcinoma of the head or neck, clinically staged T2-T4 based on AJCC staging * Clinically and radiographically regional node-negative (no evidence of regional lymph node metastasis or distant metastasis) * Able to undergo general anesthesia for sentinel lymph node biopsy * Able to undergo CT scan with contrast or MRI with contrast * Undergo surgical resection (Moh's or micrographic resection or standard excision with sentinel lymph node biopsy) within 8 weeks of imaging Exclusion Criteria: * Clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases * Known biopsy proven synchronous primary cutaneous squamous cell carcinoma * Pregnant patients * Patients unable to undergo general anesthesia * Patient unable to receive contrasted imaging studies * Patient unable to receive and/or allergic to 99m-Technetium sulfur colloid
Contact & Investigator
Jessica Yesensky, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT05108090 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05108090 currently recruiting?
Yes, NCT05108090 is actively recruiting participants. Contact the research team at ayekinn@iu.edu for enrollment information.
Where is the NCT05108090 trial being conducted?
This trial is being conducted at Indianapolis, United States.
Who is sponsoring the NCT05108090 clinical trial?
NCT05108090 is sponsored by Indiana University. The principal investigator is Jessica Yesensky, MD at Indiana University. The trial plans to enroll 94 participants.