Using diffusion MRI to assess treatment response in head and neck cancer
Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer
This study is testing a new type of MRI to see if it can help doctors understand how well treatments are working for people with head and neck cancer without needing contrast dyes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | NYU Langone Health Academic / other |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT04251481 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of quantitative diffusion MRI (dMRI) methods to accurately assess treatment response in patients with head and neck cancer. It focuses on the t-dependency of dMRI metrics over a range of diffusion times to determine the optimal time for evaluating treatment effects. The study aims to measure water exchange time in cancer cells and assess tumor perfusion status without using contrast agents. By analyzing these parameters, the research seeks to enhance the understanding of tumor behavior and treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates include treatment-naïve patients with head and neck squamous cell carcinoma (HNSCC) and metastatic lymph nodes, aged 18 or older.
Not a fit: Patients with contraindications to MRI, such as those with electrical or ferromagnetic implants, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive imaging method to better evaluate treatment responses in head and neck cancer patients.
How similar studies have performed: Previous studies have shown promise in using diffusion MRI metrics for assessing treatment response in various cancer types, indicating potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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. Exclusion Criteria: * Subjects who have the following contraindications to MRI: * 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 * Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study. * Subjects who are pregnant
Where this trial is running
New York, New York and 1 other locations
- NYU Langone — New York, New York, United States (Recruiting)
- Weill Cornell Medical College — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Elcin Zan, MD — NYU Langone
- Study coordinator: Resma Gadde
- Email: resma.gadde@nyulangone.org
- Phone: 646-501-4320
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.