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

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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07127614

Enrollment

Registered

2025-08-17

Start date

2025-08-10

Completion date

2026-01-31

Last updated

2025-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Squamous Cell Carcinoma Mouth

Keywords

squamous cell carcinoma, MRI, diagnostic accuracy

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.

Interventions

DIAGNOSTIC_TESTMRI

pre-operative MRI scan

DIAGNOSTIC_TESTHisto-Pathological examination of the resected tumor tissues

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

Study design

Observational model

OTHER

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

Egypt

Contacts

Primary ContactIslam M Ali, MSc

islamelayat@gmail.com+201274454102

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026