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

Head and Neck Squamous Cell Carcinoma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02862678
• Other study ID #: PA13048
• Status: Completed
• Phase: N/A
• Start date: April 2014
• Est. completion date: April 23, 2019

Study information

• Verified date: June 2020
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: April 23, 2019
• Est. primary completion date: March 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Recurrence
• Squamous Cell Carcinoma of Head and Neck

Intervention

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).

Locations

Country	Name	City	State
France	Chu de Reims	Reims

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tumor recurrence	positive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy	12 months
Secondary	residual tumors	positive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy	6 months