Using sentinel lymph node biopsy to assess cutaneous squamous cell carcinoma in the head and neck
Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
NA · Indiana University · NCT05108090
This study is testing if a special biopsy can help find hidden tumors in patients with a certain type of skin cancer in the head and neck to see if they need more intense treatment.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 94 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Indiana University (other) |
| Locations | 1 site (Indianapolis, Indiana) |
| Trial ID | NCT05108090 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of sentinel lymph node biopsy (SLNB) in detecting tumor deposits in patients with cutaneous squamous cell carcinoma (cSCC) of the head and neck. It focuses on patients who are clinically staged as T2-T4 and have no evidence of regional lymph node metastasis. The study aims to improve the identification of high-risk patients who may benefit from more aggressive treatment strategies. Participants will undergo SLNB along with surgical resection within eight weeks of imaging to evaluate the presence of undetected tumor deposits.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with invasive cutaneous squamous cell carcinoma of the head or neck that is clinically staged T2-T4 and node-negative.
Not a fit: Patients with evidence of metastasis, multiple primary tumors, or those unable to undergo general anesthesia or imaging studies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better detection of metastasis in cSCC patients, potentially improving treatment outcomes.
How similar studies have performed: Previous studies have shown promise in using sentinel lymph node biopsy for other types of cancers, suggesting potential success for this approach in cSCC.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Indianapolis, Indiana
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis, Indiana, United States (RECRUITING)
Study contacts
- Principal investigator: Jessica Yesensky, MD — Indiana University
- Study coordinator: Azeezat Yekinni
- Email: ayekinn@iu.edu
- Phone: 317-529-6883
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Squamous Cell Carcinoma, Nonmelanoma Skin Cancer, Cutaneous Squamous Cell Carcinoma, sentinel lymph node biopsy