Primary Tumor Depth of Invasion and Lymph Node Management in Oral Squamous Cell Carcinoma

Al-Azhar University

Status: Not yet enrolling

Conditions: Squamous Cell Carcinoma Mouth

Treatments: Diagnostic Test: MRI; Diagnostic Test: Histo-Pathological examination of the resected tumor tissues

Study type: Observational

Funder types: Other

Identifiers

NCT07127614

1008/2042

Details and patient eligibility

About

To evaluate the diagnostic accuracy of preoperative MRI in the determination of the primary tumor depth of invasion (DOI) as a predictor factor in neck lymph nodes management in T1T2N0 oral cavity squamous cell carcinomas as compared to the pathological depth of invasion

Full description

A diagnostic accuracy study comparing preoperative MRI scans to pathological examination of the resected oral squamous cell carcinoma with lymph nodes to determine the depth of invasion.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center AJCC 8th edition
• The primary tumor has a depth of invasion (DOI) greater than 4 mm
• Clinical N0 status confirmed by reasonable parameters includes computed tomography CT, MRI, -Ultrasonography,( US fine needle aspiration in suspected lymph nodes )
• The primary tumor must be reliably resected to a clear margin without the need for entry of the neck for reconstruction

Exclusion criteria

• Patients with T3T4 OCSCC
• Proven or suspected positive neck node
• Patient with distant metastasis
• Patient with gross injury to the neck that precludes proper surgical dissection.
• Patient with a history of radiotherapy to the neck
• Recurrent cases of OCSCC or recurrent node disease
• Patient with previous neck node biopsy or previous neck dissection
• Patient with a medical condition or performance that interferes with the surgical intervention as judged by the specialist physician

Trial design

25 participants in 1 patient group

study group

Description:

Patients with biopsy proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by American Joint cancer center AJCC 8th edition

Treatment:

Diagnostic Test: Histo-Pathological examination of the resected tumor tissues

Diagnostic Test: MRI