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

Not yet recruiting

• Conditions: Squamous Cell Carcinoma Mouth

• Registration Number: NCT07127614
• Lead Sponsor: Al-Azhar University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2025-07-30
• Status Verified: 2025-08
• Study Start: 2025-08-10
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-17
• Last Update Posted: 2025-08-17
• Primary Completion: 2026-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 25

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	immediately after the surgery	determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion

Trial Locations

Locations (1)

AL Sayed Galal Hospital Al-Azhar University; 🇪🇬 Cairo, Egypt