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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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02862678
Acronym
ORODIFF
Enrollment
59
Registered
2016-08-11
Start date
2014-04-01
Completion date
2019-04-23
Last updated
2026-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Squamous Cell Carcinoma

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.

Interventions

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

Sponsors

CHU de Reims
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
tumor recurrence12 monthspositive histological sample to squamous cell carcinoma between 6 and 12 months after treatment by radiochemotherapy

Secondary

MeasureTime frameDescription
residual tumors6 monthspositive histological sample to squamous cell carcinoma in the 6 months after treatment by radiochemotherapy

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026