Oral Squamous Cell CarcinomaDECT-CEcoNCT07343271
Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx
An observational study of Oral Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 11 Jul 2025to 11 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service d'ORL et de Chirurgie Cervico-faciale - CHU de Strasbourg - France
Strasbourg, 67091
Philippe Schultz, MD, PhD, 33 3 88 12 76 36, philippe.schultz@chru-strasbourg.fr
Philippe Schultz, MD, PhD
About this study
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.
- Keywords
- Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, TNM stage of the tumor
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2026
- Study start11 Jul 2025
- Primary completionJul 2026 (estimated)
- Study completion11 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07343271
- Sponsor's protocol ID
- 9773
- Acronym
- DECT-CEco
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-energy CT vs. MRI in the Evaluation of Squamous Cell Carcinomas of the Oral Cavity and Oropharynx
- ClinicalTrials.gov ID
- NCT07343271
- Acronym / sponsor ID
- DECT-CEco / 9773
- Keywords
- Oral Squamous Cell Carcinoma, Oropharyngeal Squamous Cell Carcinoma, TNM stage of the tumor
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- 11 Jul 2026 (estimated)
- First posted
- 15 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient presenting with oral or oropharyngeal squamous cell carcinoma proven by histopathological analysis of a biopsy
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- A lesion other than oral or oropharyngeal squamous cell carcinoma
- A labial location
- A contraindication to performing one or both of the imaging examinations.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oral Squamous Cell Carcinoma and Oropharyngeal Squamous Cell Carcinoma, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Philippe Schultz, MD, PhD (33 3 88 12 76 36, philippe.schultz@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall agreement established by interclass correlation on the T stage of TNM (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.