Evaluating the consistency of ADC maps in head and neck cancer
Repeatability and Reproducibility of the ADC Map in Head and Neck Cancer. Prospective Multicenter Study
Regina Elena Cancer Institute · NCT06749301
This study is testing if a special type of MRI scan can consistently show changes in head and neck cancer to help doctors track how well treatments are working.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Regina Elena Cancer Institute (other) |
| Locations | 1 site (Rome) |
| Trial ID | NCT06749301 on ClinicalTrials.gov |
What this trial studies
This study evaluates the repeatability and reproducibility of Apparent Diffusion Coefficient (ADC) maps in patients with head and neck cancer, focusing on both primary and non-primary lesions in lymph nodes. It employs a standardized diffusion-weighted imaging (DWI) acquisition protocol using 1.5 T or 3 T MRI machines across multiple centers. The goal is to ensure that ADC maps provide reliable and consistent imaging results that can aid in the assessment of cancer progression and treatment response.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary squamous cell carcinoma of the hypopharynx, oropharynx, or oral cavity, who have a visible lesion on DWI images.
Not a fit: Patients with incomplete DWI image acquisition or significant artifacts that hinder analysis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of imaging assessments in head and neck cancer, leading to better treatment decisions.
How similar studies have performed: While this study focuses on the repeatability of ADC maps, similar imaging studies have shown promise in improving diagnostic accuracy in cancer assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Rome
- IRCCS National Cancer Institute "regina Elena" — Rome, Italy (RECRUITING)
Study contacts
- Study coordinator: Simona Marzi, Doctor
- Email: simona.marzi@ifo.it
- Phone: +39 06 526666238
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Carcinoma