NCT04251481Active, not recruiting
Diffusion MRI for Head and Neck Cancer
Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer
Source: ClinicalTrials.gov · Last updated 22 Jan 2026
Brief summary (registry, in English)
The proposed study is to investigate the feasibility of using quantitative diffusion MRI (dMRI) methods for accurate and comprehensive assessment of treatment response. dMRI is a powerful tool to probe treatment-induced change in tumors. It is a unique in vivo imaging technique sensitive to cellular microstructures at the scale of water diffusion length on the order of a few microns. Previous studies have shown that both diffusion coefficient D and diffusional kurtosis coefficient K are promising imaging markers of (i) cell viability which can be used for evaluation of early treatment response. However, it is often underappreciated that these dMRI metrics are not fixed constants, but rather functions of the diffusion time t, D(t) and K(t); their t-dependency is determined by tissue properties, such as cell size and membrane permeability of tissue. D(t) and K(t) of tumors can vary substantially depending on t in the range of diffusion times (30-100 ms) typically used in clinical scan.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 16 (actual)
- First submitted
- 8 Jan 2020
- Start date
- 16 Oct 2019
- Primary completion date
- 30 Apr 2026
- Lead sponsor
- NYU Langone Health
- Diseases
- Head and neck cancer
- NCT number
- NCT04251481
What you commit to
- Study type: Interventional
- Participants enrolled: 16
- From 16 Oct 2019 to the primary completion date, 30 Apr 2026
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants
- History of seizures
Lab values
- Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
Other
- Subjects who have the following contraindications to MRI:
- Subjects who are pregnant
Who the study is looking for
- ARM 1
- Treatment-naïve HNSCC patients with metastatic lymph nodes prior to surgery or chemoradiation therapy
- Age 18 or older
- Subjects without capacity to consent will not be enrolled.
- Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
- ARM 2
- Treatment-naïve HNSCC patients with metastatic lymph nodes who will undergo standard-of-care chemoradiation therapy
- Age 18 or older
- Subjects without capacity to consent will not be enrolled.
- Subjects will be asked to verbalize understanding of the key elements, for non-English speaking patients, institutional translation services will be utilized.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Weill Cornell Medical College Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| NYU Langone Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.