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

January 6, 2026 updated by: University Hospital, Strasbourg, France
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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Strasbourg, France, 67091
        • Recruiting
        • Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
        • Principal Investigator:
          • Philippe Schultz, MD, PhD
        • Contact:
        • Principal Investigator:
          • Thibault DEDIEU, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patient presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall agreement established by interclass correlation on the T stage of TNM
Time Frame: Up to 12 months

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
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 11, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 11, 2026

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 15, 2026

Study Record Updates

Last Update Posted (Actual)

January 15, 2026

Last Update Submitted That Met QC Criteria

January 6, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9773

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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