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

Not Applicable

Completed

• Conditions: Head and Neck Squamous Cell Carcinoma
• Interventions: Other: diffusion-weighted MRI

• Registration Number: NCT02862678
• Lead Sponsor: CHU de Reims

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.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-11
• Primary Completion: 2019-03-23
• Study Completion: 2019-04-23
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-15
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with head and neck squamous cell carcinoma	diffusion-weighted MRI	-

Primary Outcome Measures

Name	Time	Method
tumor recurrence	12 months	positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy

Secondary Outcome Measures

Name	Time	Method
residual tumors	6 months	positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy

Trial Locations

Locations (1)

Chu de Reims; 🇫🇷 Reims, France