Sentinel lymph node biopsy for cutaneous squamous cell carcinoma of the head and neck
J
Jessica Yesensky, MD
Primary Investigator
Enrolling By Invitation
18-100 years
All
Phase
N/A
94 participants needed
2 Locations
Overview
What is the purpose of this study?
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.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Consistent with most oncology trials, patients are not actively “recruited,” but are screened by their physician for appropriate clinical trial(s) at the time of their routine clinic visit. Occasionally, a patient may be a self-referral or physician referral, but are still screened for appropriate clinical trials at the time of their routine clinic visit. PI and staff may send copies of relevant consent forms to these patients to look over prior to actually consenting or enrolling them. This may take place at the patient's visit at which the consent is presented or the patient's next visit to the outpatient hematology/oncology clinic.
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office
Email: iutrials@iu.edu
Phone: (317) 278-5632
Description
What will happen during the study?
- During a baseline visit, researchers will complete a biopsy to confirm diagnosis of invasice cutaneous squamous cell carcinoma, as well as Spectral CT with contrast, MRI with contrast, PET-CT and/or PET-MRI.
- During intervention, researchers will complete a pre-operative lymphoscintigraphy, surgery (either Moh's micrographic or standard excision), and gene profiling.
- Participants will complete a follow-up visit approximately 1 week and 4 weeks after surgery, as well as every 3 months thereafter for 1 year. Researchers will review participant medical records related to the outcome of their SLNB for up to 2 years following surgery.
Eligibility
You may be eligible for this study if you meet the following criteria:
-
Conditions:
Squamous Cell Carcinoma, Nonmelanoma Skin Cancer
-
Age: Between 18 Years - 100 Years
-
Gender: All
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 4 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
Updated on
28 Sep 2024.
Study ID: CTO-OTHN-CC-IUSCC-0741, 2008504996
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