Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

NCT04664582 | Unknown

• 1 other identifier: SLNB for SCC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Current guidelines in management of regional lymph node metastases for cSCC patients include surgical resection with or without adjuvant therapy as well as chemotherapy and interdisciplinary management; in advanced disease, supportive and palliative care is recommended. These guidelines also define the role of SLNB in management of high-risk cSCC as unclear and suggest further studies need to determine its utility and indications11. Currently, routine practice of performing SLNB in cSCC varies across Quebec and within Canada. At many institutions, SLNB is not routinely performed on patients with cSCC. The current standard of treatment is to observe closely when a patient is deemed to have a high-risk cancer, and if they have clinical or radiological findings of lymphadenopathy, a formal surgical neck dissection is performed. Given the comorbidities and risks involved in treatment of regional lymph nodes in cSCC, the role of SLNB in cSCC patients needs further clarification. This multicentre prospective study aims to better clarify this role and formulate suggested criteria for its indications.

Conditions

Cutaneous Squamous Cell Carcinoma; Sentinel Lymph Node

Outcome Measures

Primary Outcomes (1)

• predictive value of sentinel lymph node biopsy in cutaneous squamous cell carcinoma

  1 month after feasibility recruitment completed (anticipated Dec 2021)

Secondary Outcomes (1)

• disease free five year survival

  5 years post intervention

Study Arms (2)

Sentinel Lymph Node Biopsy

EXPERIMENTAL

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.

Procedure: Sentinel Lymph Node Biopsy

Standard of Care

NO 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.

Interventions

Sentinel Lymph Node Biopsy PROCEDURE

see intervention group description

Sentinel Lymph Node Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Immunocompromised
• Size more than 2 cm
• Depth more than 6 mm
• Poorly differentiated histology
• Perineural invasion \> 0.1mm
• Extensive lymphovascular invasion

You may not qualify if:

• Evidence of lymph node metastasis (clinical, radiological, or pathological)
• Previous surgery altering lymphatic drainage of the head and neck, such as a prior neck dissection or prior neck irradiation
• Pregnancy of breast-feeding

Sponsors & Collaborators

• Jewish General Hospital: lead
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

Jewish General Hospital

Montreal, Quebec, H3T 1E2, Canada

RECRUITING

MeSH Terms

Interventions

Sentinel Lymph Node Biopsy

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Alex Mlynarek, MD

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sena Turkdogan, MD

CONTACT

5147308461; sena.turkdogan@mail.mcgill.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Treatment with sentinel lymph node biopsy cannot be masked for the participant, care provider, nor investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 6, 2020
• First Posted: December 11, 2020
• Study Start: November 26, 2020
• Primary Completion: December 30, 2022
• Study Completion: December 30, 2023
• Last Updated: April 5, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)