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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2019

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.

Interventions

  • Other: diffusion-weighted MRI
    • Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).

Arms, Groups and Cohorts

  • Experimental: Patients with head and neck squamous cell carcinoma

Clinical Trial Outcome Measures

Primary Measures

  • tumor recurrence
    • Time Frame: 12 months
    • positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy

Secondary Measures

  • residual tumors
    • Time Frame: 6 months
    • positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • CHU de Reims
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Marc LABROUSSE, mlabrousse@chu-reims.fr

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