Comparing dual-energy CT and MRI for staging oral and oropharyngeal squamous cell carcinoma
Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx
University Hospital, Strasbourg, France · NCT07343271
This will test whether 40 keV dual-energy CT can replace a contrast-enhanced neck and facial MRI for staging adults with oral or oropharyngeal squamous cell carcinoma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 30 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Strasbourg, France (other) |
| Locations | 1 site (Strasbourg) |
| Trial ID | NCT07343271 on ClinicalTrials.gov |
What this trial studies
This observational study compares 40 keV dual-energy CT (with the BOLT maneuver) to standard contrast-enhanced cervicofacial MRI for determining TNM stage in adults with oral or oropharyngeal squamous cell carcinoma. Eligible participants have biopsy-proven disease and undergo both imaging exams as part of their pre-therapeutic workup. Imaging results will be compared to determine concordance and to test non-inferiority of DECT relative to MRI for tumor and nodal staging. If DECT proves non-inferior, it could shorten the pre-treatment imaging pathway and reduce reliance on MRI resources.
Who should consider this trial
Good fit: Adults (≥18) with biopsy-confirmed oral or oropharyngeal squamous cell carcinoma who have had an ENT nasofibroscopy and both a contrast-enhanced cervicofacial MRI and contrast-enhanced DECT with the BOLT maneuver.
Not a fit: Patients with non-squamous tumors, lesions located on the lip (labial), or with contraindications to MRI or CT are unlikely to benefit from replacing MRI with DECT.
Why it matters
Potential benefit: If successful, patients could avoid an additional MRI, get staged faster, begin treatment sooner, and free up limited MRI slots.
How similar studies have performed: Smaller studies have suggested dual-energy CT can improve soft-tissue contrast in head and neck cancer, but direct non-inferiority to MRI for TNM staging is not yet established.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Strasbourg
- Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France — Strasbourg, France (RECRUITING)
Study contacts
- Study coordinator: Philippe Schultz, MD, PhD
- Email: philippe.schultz@chru-strasbourg.fr
- Phone: 33 3 88 12 76 36
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, TNM stage of the tumor