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Completed

NCT Number: NCT06749301

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

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

Completed

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Key information

Conditions

Head and Neck Carcinoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS National Cancer Institute "regina Elena"

Rome, Italy, 00144

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Regina Elena Cancer Institute

Other

Registry information

Acronym: ADC/SCC oss

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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