Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study (ADC/SCC oss)

Regina Elena Cancer Institute

Status: Enrolling

Conditions: Head and Neck Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT06749301

RS1861/23

Details and patient eligibility

About

Evaluation of the repeatability and reproducibility of ADC maps in both primary and non-primary lesions lymph nodes in patients with head and neck cancer, using an acquisition protocol Standardized DWI

Full description

DWI imaging consists of a spin-echo echo-planar sequence (SE-EPI) that will be acquired with 1.5 T or 3 T tomographs according to the equipment of the individual centers involved, setting the acquisition parameters after the administration of any contrast medium.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age over 18 years;
• primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity; confirmed by histology;
• a lesion visible on at least three consecutive DWI images, with a minimum diameter of 2 cm;
• specific written informed consent;

Exclusion criteria

• incomplete acquisition of DWI images;
• presence of artifacts that do not allow quantitative analysis of DWI images;
• performance status 2 or more according to Zubrod.

Trial design

150 participants in 1 patient group

Patients with primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity c

Description:

Patients over 18 years of age with primary squamous cell carcinoma of the head and neck (hypopharynx, oropharynx or oral cavity, confirmed by histology) will be prospectively enrolled and, according to standard procedures, will have to undergo an MRI examination for diagnostic purposes.