Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study

Regina Elena Cancer Institute58 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Head and Neck Carcinoma

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

IRCCS National Cancer Institute "regina Elena"

Rome, Italy, Italy

Outcomes

Primary Outcomes

Evaluation of the short-term repeatability of ADC maps in both primary and nodal lesions in patients with squamous cell carcinomas (SCC) of the head and neck

A standardized and shared DWI acquisition protocol will be used at a multicenter level. DWI imaging consists of a spin-echo echo-planar (SE-EPI) sequence that will be acquired with 1.5 T or 3 T tomographs, setting the acquisition parameters, after the administration of the contrast medium (if any) (in order to ensure that the second DWI acquisition is performed under the same conditions as the first). The MRI study must include at least one T2-weighted axial sequence, whose images will be used to support the delineation of the lesions.

Time frame: 18 months

Data from ClinicalTrials.gov

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