Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity Hospital, Strasbourg, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
A lesion other than oral or oropharyngeal squamous cell carcinoma
A labial location
A contraindication to performing one or both of the imaging examinations.
Trial population
Adult patient presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Overall agreement established by interclass correlation on the T stage of TNM
Overall agreement established by interclass correlation on the T stage of TNM between the radiological analysis of the DECT 40 kev BOLT, and of the MRI, compared to the reference T stage of TNM from the RCP: Overall agreement: This means: do the methods give the same results? We want to know if DECT and MRI reach the same T stage for the same patient. Example: DECT: T3 MRI: T3 Result: Good agreement DECT: T2 MRI: T3 Result: Disagreement
Time frame
Up to 12 monthsSponsors and contacts
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Source ClinicalTrials.gov