About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial population
Patients with biopsy-proven oral squamous cell carcinoma with the edition T1or T2 N0 based on TNM staging by the American Joint Cancer Center
Trial design
Other
Cross-sectional
Treatments tested in this trial
MRI
Diagnostic testpre-operative MRI scan
Histo-Pathological examination of the resected tumor tissues
Diagnostic testhisto-pathological examination of the resected tumor tissues with the lymph nodes involved to determine the pathological depth of invasion
Treatment groups
Trial outcomes
Primary outcomes
Diagnostic accuracy
determination of the diagnostic accuracy of MRI in determining the depth of invasion compared to the pathological depth of invasion
Sponsors and contacts
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