Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04251481

Diffusion MRI for Head and Neck Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Head Cancer Neck Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone, New York, United States

Loading trial locations.

About this study

This study will investigate the t-dependency of dMRI over a range of diffusion times (30-500 ms) to determine an optimal diffusion time for treatment response assessment when only one diffusion time needs to be used, particularly in routine clinical studies. Furthermore, the data with multiple diffusion times will also be used to measure the water exchange time of cancer cells. Exchange time has been studied using Dynamic Contrast Enhanced (DCE) MRI by multiple groups including ours, and has been suggested as a marker of (ii) cellular metabolism that regulates the ATP-dependent ion channels co-transporting water molecules. The study will measure with dMRI, without using a contrast agent. The investigators also demonstrated that Intra-Voxel Incoherent Motion (IVIM) MRI metrics (pseudo diffusivity, Dp; perfusion fraction, fp), from multiple b-values at a fixed diffusion time, can be used to assess the perfusion status of tumor and they are also associated with tumor interstitial fluid pressure. The IVIM effect has been observed in various cancer types (33-39) and animal tumor models. The product fp*Dp - a quantity including both blood volume and velocity information - is considered as a parameter analogous to (iii) perfusion flow .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PET/MRI with FDG

Radiation

For the PET/MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for both the MRI and PET portions of the examination. The dye for the PET portion will be 18F-fluorodeoxyglucose (FDG). FDG is an FDA-approved radioactive substance (isotope) that contains chemicals that can be traced by PET/MRI. The dye for the MRI portion will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

MRI scan without contrast

Radiation

MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner to scan the neck ; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

MRI with gadolinium

Radiation

For the MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for MR scans. The dye for the MRI will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.

Primary outcomes

  1. Intra-class Correlation (ICC)

    Time frame: 6 weeks

    Estimated components from a random effects model in each dMRI measure will be used to compute intra-class correlation as estimates of repeatability of each measure.

  2. Intra-subject Coefficient of Variation (CV)

    Time frame: 6 weeks

    Estimated components from a random effects model in each dMRI measure will be used to compute intra-subject coefficient of variation as estimates of repeatability of each measure.

  3. Overall Response Rate (ORR)

    Time frame: 6 weeks

    Binary classification of treatment response as complete response (CR) versus partial response (PR) for participants at the end of the chemoradiation therapy assessed by clinical/radiological reports. CR will include the cases with complete disappearance of any clinically detectable tumor mass, while PR will include cases with stable disease and progressive disease.

Secondary outcomes

  1. Progression-Free Survival (PFS)

    Time frame: 2 Years Post-Treatment

    Binary indicator of whether patients showed progression-free survival at 2 years post treatment on the standard-of-care follow-up exams. PFS is the length of time that a patient lives with the disease but it does not get worse.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

Assessment of the Role of Diffusion MRI Changes During Chemoradiation Treatment of Head and Neck Cancer

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Feb 5, 2020
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.