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NCT Number: NCT07127614

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

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

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Key information

Conditions

Squamous Cell Carcinoma Mouth Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MRI

Diagnostic Test

pre-operative MRI scan

Other names: index test

Histo-Pathological examination of the resected tumor tissues

Diagnostic Test

histo-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion

Other names: Reference test

Primary outcomes

  1. Diagnostic accuracy

    Time frame: immediately after the surgery

    determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion

Study contacts

Contact information is provided by the study sponsor or research team.

Islam M Ali, MSc

CONTACT

[email protected]

+201274454102

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

The Relationship Between Primary Tumor Depth of Invasion and Neck Lymph Nodes Management in T1T2N0 Oral Cavity Squamous Cell Carcinomas

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 17, 2025
Registry last updated
Aug 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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