Diffusion MRI for Head and Neck Cancer

Not Applicable

Recruiting

• Conditions: Head Cancer Neck

• Registration Number: NCT04251481
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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 .

Study Timeline

• Study Start: 2019-10-16
• Study First Submitted: 2020-01-08
• Study First Submitted QC: 2020-01-30
• Study First Posted: 2020-02-05
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-10
• Last Update Posted: 2025-02-11
• Primary Completion: 2026-04-30
• Study Completion: 2026-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Intra-class Correlation (ICC)	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.
Overall Response Rate (ORR)	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.
Intra-subject Coefficient of Variation (CV)	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.

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival (PFS)	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.

Trial Locations

Locations (2)

NYU Langone; 🇺🇸 New York, New York, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States