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NCT Number: NCT07343271

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France

Strasbourg, 67091, France

Location status: Recruiting

Location contact

Philippe Schultz, MD, PhD

CONTACT

[email protected]

33 3 88 12 76 36

Philippe Schultz, MD, PhD

PRINCIPAL_INVESTIGATOR

Thibault DEDIEU, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe Schultz, MD, PhD

CONTACT

[email protected]

33 3 88 12 76 36

Sponsors and collaborators

Lead sponsor

University Hospital, Strasbourg, France

Other

Registry information

Acronym: DECT-CEco

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 15, 2026
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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