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Recruiting NCT07343271

Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx

Observational Oral Squamous Cell Carcinoma Oropharyngeal Squamous Cell Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

The diagnostic and pre-therapeutic assessment of squamous cell carcinomas requires a neck and chest CT scan and a neck and facial MRI, which is the most effective examination, to establish the TNM stage of the tumor. However, obtaining this complete assessment can delay treatment. Confirmation of the non-inferiority of 40keV dual-energy CT in BOLT compared to MRI would spare the patient an additional MRI examination, speed up the pre-treatment assessment, reduce the loss of opportunity due to delayed treatment, and free up MRI imaging slots, which are still insufficient in the region.

Primary outcome measures

  • Overall agreement established by interclass correlation on the T stage of TNM [Time frame: Up to 12 months]

Eligibility criteria

Inclusion criteria

  • Adult patient (≥18 years)
  • presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy
  • having undergone a clinical examination with nasofibroscopy by an ENT surgeon specializing in cancer surgery
  • a contrast-enhanced cervicofacial MRI
  • and a contrast-enhanced cervicofacial DECT with BOLT maneuver.

Exclusion criteria

  • A lesion other than oral or oropharyngeal squamous cell carcinoma
  • A labial location
  • A contraindication to performing one or both of the imaging examinations.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

France · 1 center
  • Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France — Strasbourg

Identifiers

NCT: NCT07343271 · 9773

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗