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

Recruiting

• Conditions: Head and Neck Carcinoma

• Registration Number: NCT06749301
• Lead Sponsor: Regina Elena Cancer Institute

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2023-09-11
• Status Verified: 2024-12
• Study First Submitted: 2024-12-19
• Study First Submitted QC: 2024-12-19
• Last Update Submitted: 2024-12-19
• Study First Posted: 2024-12-27
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-03-11
• Study Completion: 2025-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	18 months	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.

Trial Locations

Locations (1)

IRCCS National Cancer Institute "regina Elena"; 🇮🇹 Rome, Italy