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

NCT07343271 | Recruiting

• 1 other identifier: 9773
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Keywords

Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma; TNM stage of the tumor

Outcome Measures

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

  Up to 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Strasbourg, France: lead

Study Sites (1)

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

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Central Study Contacts

Philippe Schultz, MD, PhD

CONTACT

33 3 88 12 76 36; philippe.schultz@chru-strasbourg.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: January 15, 2026
• Study Start: July 11, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 11, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

FR (1)