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

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

Study Overview

• Status: Completed
• Conditions: Head and Neck Carcinoma

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 Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

• Italy
  • Italy
    • Rome, Italy, Italy, 00144
      • IRCCS National Cancer Institute "regina Elena"

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with SCC of the head and neck who, according to standard procedures, will have to undergo an MRI examination fordiagnostic purposes.

Patients must also meet the inclusion criteria

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients with primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity c; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	18 months

Collaborators and Investigators

• Sponsor: Regina Elena Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2023
• Primary Completion (Actual): March 11, 2025
• Study Completion (Actual): March 11, 2025

Study Registration Dates

• First Submitted: December 19, 2024
• First Submitted That Met QC Criteria: December 19, 2024
• First Posted (Actual): December 27, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: RS1861/23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No