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
1 other identifier
interventional
59
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
August 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
April 23, 2019
CompletedJanuary 21, 2026
June 1, 2020
5 years
August 8, 2016
January 19, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
tumor recurrence
positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy
12 months
Secondary Outcomes (1)
residual tumors
6 months
Study Arms (1)
Patients with head and neck squamous cell carcinoma
EXPERIMENTALInterventions
Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- patients with contraindications for MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CHU de Reimslead
Study Sites (1)
Chu de Reims
Reims, 51092, France
Related Publications (1)
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.
PMID: 32422975BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
August 11, 2016
Study Start
April 1, 2014
Primary Completion
March 23, 2019
Study Completion
April 23, 2019
Last Updated
January 21, 2026
Record last verified: 2020-06