← Back to Search

Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma

N/A

Waitlist Available

Led By Alex Mlynarek, MD

Research Sponsored by Jewish General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is investigating whether sentinel lymph node biopsy (SLNB) should be routine practice for people with a type of skin cancer called cutaneous squamous cell carcinoma (cSCC).

Who is the study for?

This trial is for individuals with a type of skin cancer called cutaneous Squamous Cell Carcinoma (cSCC) on the head or neck. Eligible participants must have tumors deeper than 6mm, poorly differentiated cells, nerve invasion over 0.1mm, extensive vessel invasion, tumors larger than 2cm, or be immunocompromised. Those with known lymph node metastases, prior surgeries affecting neck lymph drainage, or who are pregnant/breastfeeding cannot participate.

What is being tested?

The study is testing Sentinel Lymph Node Biopsy (SLNB) in patients with high-risk cSCC to see if it's effective and when it should be used. Currently there's no consensus on using SLNB routinely; this research could lead to new guidelines for treating regional lymph nodes in these patients.

What are the potential side effects?

While specific side effects aren't listed here, typical risks associated with surgical biopsies like SLNB may include pain at the biopsy site, infection risk from the incision made during surgery and potential complications related to anesthesia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Sentinel Lymph Node BiopsyExperimental Treatment1 Intervention

Lymphoscintigraphy will be ordered alongside usual pre-operative investigations. Intra-operatively, the excision of the primary tumor will be done with the aim of histologically clear margins and appropriate closure as per routine practice at the operating surgeon's discretion. The patients are injected with technicium 99 pre-operatively and a sentinel lymph node biopsy will be performed with a handheld gamma probe.

Group II: Standard of CareActive Control1 Intervention

These patients will be treated with standard of care, which is wide local excision of the primary tumor without performance of sentinel lymph node biopsy, if not indicated.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sentinel Lymph Node Biopsy

2004

Completed Phase 3

~350

Do I qualify?Apply below to find out