Actively Recruiting
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
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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
Eligibility Criteria
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
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
Actively Recruiting
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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