Actively Recruiting

Age: 18Years +
All Genders
ID06749301

Repeatability and Reproducibility of ADC Maps in Head and Neck Cancer Using Standardized DWI A Prospective Multicenter Observational Study

Led by Regina Elena Cancer Institute ยท Updated on 2024-12-27

150

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying the consistency and reliability of ADC maps in imaging for patients with head and neck cancer, specifically focusing on squamous cell carcinomas (SCC) of the hypopharynx, oropharynx, or oral cavity. This study evaluates both primary tumors and lymph node lesions using a standardized diffusion-weighted imaging (DWI) protocol to improve diagnostic imaging techniques. The imaging uses a spin-echo echo-planar sequence (SE-EPI) performed on 1.5 T or 3 T MRI scanners, depending on the equipment available at each participating center. These images are acquired after administering any required contrast medium, following a standard protocol designed to ensure uniform data collection across multiple centers. Participants will undergo DWI scans where researchers will assess the repeatability of ADC maps in both primary and nodal lesions over an 18-month period. The main measurement is how consistent these imaging results are over time, helping to improve the reliability of cancer imaging. The study also monitors for image quality and any artifacts that may affect analysis.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years
  • Primary squamous cell carcinoma (SCC) of the hypopharynx, oropharynx, or oral cavity confirmed by histology
  • Lesion visible on at least three consecutive diffusion-weighted imaging (DWI) scans with a minimum diameter of 2 cm
  • Provided specific written informed consent
Not Eligible

You will not qualify if you...

  • Incomplete acquisition of diffusion-weighted imaging (DWI) scans
  • Presence of imaging artifacts preventing quantitative analysis of DWI images
  • Performance status of 2 or higher according to Zubrod scale

AI-Screening

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Trial Site Locations

Total: 1 location

1

IRCCS National Cancer Institute "regina Elena"

Rome, Italy, 00144

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Research Team

S

Simona Marzi, Doctor

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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