- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02862678
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 (ORODIFF)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Reims, France, 51092
- CHU de Reims
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- patients with contraindications for MRI
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patients with head and neck squamous cell carcinoma
|
Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tumor recurrence
Time Frame: 12 months
|
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
residual tumors
Time Frame: 6 months
|
positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy
|
6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PA13048
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Clinical Trials on Head and Neck Squamous Cell Carcinoma
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Washington University School of MedicineMerck Sharp & Dohme LLCActive, not recruitingHead and Neck Cancer | Squamous Cell Carcinoma of the Head and Neck | Cancer of Head and Neck | Carcinoma, Squamous Cell of Head and Neck | Neoplasms, Head and Neck | Squamous Cell Carcinoma, Head and NeckUnited States
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Yonsei UniversityCompletedHead Neck Cancer Squamous Cell Recurrent | Head Neck Cancer Squamous Cell MetastaticKorea, Republic of
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-
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-
Wake Forest University Health SciencesNational Cancer Institute (NCI)RecruitingHead and Neck Squamous Cell Carcinoma | Recurrent Head and Neck Squamous Cell Carcinoma | Metastatic Head-and-neck Squamous-cell CarcinomaUnited States
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