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)
Primary Purpose
Head and Neck Squamous Cell Carcinoma
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
diffusion-weighted MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Head and Neck Squamous Cell Carcinoma
Eligibility Criteria
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
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with head and neck squamous cell carcinoma
Arm Description
Outcomes
Primary Outcome Measures
tumor recurrence
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
Secondary Outcome Measures
residual tumors
positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02862678
Brief 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
Acronym
ORODIFF
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
April 2014 (undefined)
Primary Completion Date
March 23, 2019 (Actual)
Study Completion Date
April 23, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with head and neck squamous cell carcinoma
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
diffusion-weighted MRI
Intervention Description
Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).
Primary Outcome Measure Information:
Title
tumor recurrence
Description
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
Time Frame
12 months
Secondary Outcome Measure Information:
Title
residual tumors
Description
positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
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
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