Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Indiana University
Disqualifiers: Pregnancy, Metastases, Allergic to contrast, others
No Placebo Group
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma?
Research shows that Sentinel Lymph Node Biopsy (SLNB) is a promising method for staging head and neck squamous cell carcinoma, as it is minimally invasive and can accurately identify lymph nodes that may contain cancer. Studies indicate that SLNB is feasible and potentially effective in evaluating neck node metastasis, which helps in planning appropriate treatment.
12345Is sentinel lymph node biopsy (SLNB) generally safe for humans?
Sentinel lymph node biopsy (SLNB) is considered a minimally invasive and generally safe procedure, initially developed for melanoma and breast cancers, and now used in head and neck cancers. It can help avoid unnecessary surgeries, reducing complications and improving quality of life.
23467How is the treatment Sentinel Lymph Node Biopsy different from other treatments for head and neck squamous cell carcinoma?
Sentinel Lymph Node Biopsy (SLNB) is unique because it is a minimally invasive procedure that helps determine if cancer has spread to the lymph nodes, which is crucial for staging and treatment planning. Unlike traditional methods that may require more extensive surgery, SLNB focuses on identifying and testing only the first few lymph nodes (sentinel nodes) that drain the cancer area, potentially reducing the need for more invasive neck dissections.
13458Eligibility Criteria
This trial is for adults over 18 with a specific skin cancer on the head or neck that hasn't spread to lymph nodes or elsewhere. They must be able to have general anesthesia, undergo certain scans with contrast, and consent to the study's procedures.Inclusion Criteria
I can safely be put under general anesthesia for a biopsy.
Ability to provide written informed consent and HIPAA authorization
Able to undergo CT scan with contrast or MRI with contrast
+4 more
Exclusion Criteria
I cannot have surgery that requires being put to sleep.
I have a confirmed skin cancer diagnosis from a biopsy.
My cancer has spread to nearby lymph nodes or other parts of my body.
+3 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Procedure/Surgery
Participants undergo Mohs micrographic surgery followed by sentinel lymph node biopsy
1 day
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after surgery and biopsy
1 year
Regular visits (in-person and virtual)
Participant Groups
The study tests if sentinel lymph node biopsy (SLNB) can detect hidden tumor cells in patients with cutaneous squamous cell carcinoma of the head or neck who don't show signs of cancer in their lymph nodes.
1Treatment groups
Experimental Treatment
Group I: Procedure/SurgeryExperimental Treatment1 Intervention
Mohs micrographic surgery followed by sentinel lymph node biopsy
Sentinel Lymph Node Biopsy is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Sentinel Lymph Node Biopsy for:
- Breast cancer
- Melanoma
- Cutaneous squamous cell carcinoma of the head and neck
🇪🇺 Approved in European Union as Sentinel Lymph Node Biopsy for:
- Breast cancer
- Melanoma
- Other types of cancer such as penile cancer, endometrial cancer, and vulvar cancer
🇨🇦 Approved in Canada as Sentinel Lymph Node Biopsy for:
- Breast cancer
- Melanoma
- Other types of cancer
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Indiana University Melvin & Bren Simon Cancer CenterIndianapolis, IN
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Who Is Running the Clinical Trial?
Indiana UniversityLead Sponsor
References
Sentinel node biopsy for early-stage oral cavity cancer: the VU University Medical Center experience. [2019]Sentinel node biopsy (SNB) in head and neck cancer is recently introduced as the staging technique of oral squamous cell carcinoma. We report the results of SNB in patients diagnosed with a T1-T2 oral squamous cell carcinoma and clinically negative (N0) neck in a single center.
Does sentinel lymph node biopsy have a role in node-positive head and neck squamous carcinoma? [2018]The objective of the study was to determine whether sentinel lymph node biopsy (SLNB) can be used to reduce clinical overstaging of cervical nodes in head and neck squamous cell carcinoma (SCC) in a developing world setting.
Sentinel node localization in head and neck tumors. [2016]Sentinel lymph node biopsy (SLNB) is a minimally invasive method that was developed to stage the regional lymphatics of patients with cutaneous melanoma. Many studies performed worldwide have shown that SLNB is a feasible method to stage the cervical lymphatics in patients with head and neck squamous cell carcinoma (HNSCC). The accuracy of SLNB in patients with HNSCC is currently under investigation in a multicenter study sponsored by the American College of Surgeons Oncology Group that compares the results of SLNB with standard elective neck dissection. Research to date has also shown that multiple SLNs and individualized drainage patterns characterize head and neck mucosal sites. These findings suggest that lymphoscintigraphy alone may be useful to delineate the lymphatic basins that require treatment in patients with HNSCC and in patients whose head and neck lymphatics are disrupted because of prior surgery or irradiation.
Diagnostic evaluation of sentinel lymph node biopsy in early head and neck squamous cell carcinoma: a meta-analysis. [2019]The purpose of this study was to evaluate the efficacy of sentinel lymph node biopsy (SLNB) in early head and neck squamous cell carcinoma (HNSCC).
Sentinel node biopsy in head and neck squamous cell carcinoma. [2009]Sentinel node biopsy (SNB) is emerging as a potential tool to evaluate neck node metastasis in head and neck cancer. The purpose of this article is to undertake a systemic review of published literature and to outline future directions for further studies.
Does sentinel lymph node biopsy in cutaneous head and neck melanoma alter disease outcome? [2016]In the head and neck region, value, reliability, and safety of sentinel lymph node biopsy (SLNB) have not yet been determined conclusively. The aim of study was to assess impact of SLNB on disease outcome in cutaneous head and neck melanoma.
[Sentinel lymph node biopsy in head and neck oncology]. [2020]Sentinel lymph node biopsy (SLNB) has been initially developed for melanoma and breast cancers. Its application in head and neck cancers is recent, probably due to the complexity of the lymphatic drainage, the proximity between the primary tumor and the lymph nodes and the critical anatomical structures (such as the facial nerve). In onco-dermatology, SLNB is validated in head and neck surgery for melanoma with Breslow thickness up to 1mm or ulceration, Merkel carcinoma and high-risk squamous cell carcinoma. Considering the malignancies of the upper aerodigestive tract, the feasibility and oncologic safety of SLNB are now established for T1-T2N0 oral and oropharyngeal squamous cell carcinomas. Thus, it could allow patients with negative sentinel nodes to avoid an unnecessary neck dissection, leading to a decrease of morbidity with an quality of life improvement. For some primary locations (e.g., anterior floor of the mouth) with high proximity between tumor and lymph nodes, it is recommended to remove the tumor before the SLNB so as to improve the detection. New techniques of detection are currently being developed with intra-operative procedures and new tracers (such as tilmanocept), leading to a better accuracy of detection and, probably, new indications.
Sentinel lymph node biopsy for cutaneous head and neck malignancies. [2015]Sentinel lymph node biopsy (SLNB) is a procedure that can provide critical information regarding pathologic lymph node status and accurate regional staging. This is very important for developing treatment plans and providing prognostic guidance for cutaneous malignancies. The head and neck (HN) region is unique from other body sites due to its complex lymphatic drainage pathways, multiple lymph node basins, proximity of important cranial nerves and potential for contralateral or bilateral drainage. These unique aspects of the HN previously created some uncertainty about the use of SLNB in the HN. This review will discuss the current reliable status of HN SLNB and provide a guide for its current application in cutaneous malignancy of the HN.