Head and Neck Squamous Cell CarcinomaORODIFFNCT02862678
Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study
A study testing diffusion-weighted MRI in people with Head and Neck Squamous Cell Carcinoma, run by CHU de Reims at 1 site in France.
Trial summary
Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma
- What is being tested?
- diffusion-weighted MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to 23 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- patients with head and neck squamous cell carcinoma
- patients with indication of a treatment by chemoradiotherapy (without surgical indication)
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Who cannot join
- patients with contraindications for MRI
Trial locations and contacts
1 site in 1 country.
About this study
Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.
Read the detailed description
study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.
compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Being tested
- diffusion-weighted MRI
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion-weighted MRIOther
Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).
| Study group | Role | What they receive |
|---|---|---|
| Patients with head and neck squamous cell carcinoma | Experimental | Not described Receives: Other: diffusion-weighted MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
tumor recurrence
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
Measured: 12 months
Secondary outcomes (1)
residual tumors
positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2016 (estimated)
- Study startApr 2014
- Primary completion23 Mar 2019
- Study completion23 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Reims
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02862678
- Sponsor's protocol ID
- PA13048
- Acronym
- ORODIFF
- Status last verified
- Jun 2020
- First submitted
- 8 Aug 2016
- Last updated
- 21 Jan 2026
- Results posted
- No
Publications
Brenet E, Barbe C, Hoeffel C, Dubernard X, Merol JC, Fath L, Servagi-Vernat S, Labrousse M. Predictive Value of Early Post-Treatment Diffusion-Weighted MRI for Recurrence or Tumor Progression of Head and Neck Squamous Cell Carcinoma Treated with Chemo-Radiotherapy. Cancers (Basel). 2020 May 14;12(5):1234. doi: 10.3390/cancers12051234.
PubMed 32422975
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of Diffusion-weighted MRI Performed in Early Post-treatment in the Occurrence of Tumor Recurrence or Progression in Head and Neck Squamous Cell Carcinoma Treated With Chemoradiotherapy: a Pilot Study
- ClinicalTrials.gov ID
- NCT02862678
- Acronym / sponsor ID
- ORODIFF / PA13048
- Conditions
- Head and Neck Squamous Cell Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- CHU de ReimsUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- 23 Mar 2019 (actual)
- Study completion
- 23 Apr 2019 (actual)
- First posted
- 11 Aug 2016 (estimated)
- 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.
Head and neck squamous cell carcinoma are frequent. The chemoradiotherapy protocols are part of the reference treatment of locally advanced stage tumors. Diffusion-weighted MRI (DW-MRI) is a non radiating imaging, not requiring injection of gadolinium, giving informations on tumor activity, based on the brownian motion of water molecules. The differences in motion are expressed by the apparent diffusion coefficient (ADC). The ADC variations reflect changes in water molecules motion and redistribution between the intra- and extracellular compartments. Several studies have shown that malignant lesions have an ADC coefficient lowered as compared to benign lesions.
Detailed description
study the diagnostic performance of diffusion MRI performed in early post treatment, notably changes in the ADC factor, in the onset of tumor recurrence or progression in patients showing no residual tumor at the end a treatment by chemoradiotherapy for squamous cell carcinoma of head and neck seat.
compare the characteristics of diffusion MRI, such as ADC coefficient, between patients with residual tumor and patients with no residual tumor after chemoradiotherapy for squamous cell carcinoma of head and neck location.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with head and neck squamous cell carcinoma | Experimental | Other: diffusion-weighted MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients with head and neck squamous cell carcinoma
- patients with indication of a treatment by chemoradiotherapy (without surgical indication)
- patient consenting to participate to the study
- patient enrolled in the national healthcare insurance program
- patient older than 18 years
Key exclusion criteria (1 listed)
- patients with contraindications for MRI
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion-weighted MRITwo diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment). | Other | Patients with head and neck squamous cell carcinoma |
Primary outcome
tumor recurrence
Time frame: 12 months
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
1 secondary outcome
residual tumors
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Background: PubMed 32422975Brenet E, Barbe C, Hoeffel C, Dubernard X, Merol JC, Fath L, Servagi-Vernat S, Labrousse M. Predictive Value of Early Post-Treatment Diffusion-Weighted MRI for Recurrence or Tumor Progression of Head and Neck Squamous Cell Carcinoma Treated with Chemo-Radiotherapy. Cancers (Basel). 2020 May 14;12(5):1234. doi: 10.3390/cancers12051234.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diffusion-weighted MRI in people with Head and Neck Squamous Cell Carcinoma, run by CHU de Reims 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 1 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: finished, as of the sponsor's last update on 21 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
tumor recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02862678, which also lists 1 linked publication.
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 21 Jan 2026.